Who is the manufacturer of Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

Surgical Instrument Service and Savings, Inc. filed the 510(k) submission for Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider (K160333).

What is the FDA product code for Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

NUJ. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

LigaSure Blunt Tip Sealer/Divider (K142929).

Who can help prepare an FDA 510(k) submission like Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

K160333 · Surgical Instrument Service and Savings, Inc. · NUJ · Jul 20, 2016 · General, Plastic Surgery

Device Facts

Record ID	K160333
Device Name	Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
Applicant	Surgical Instrument Service and Savings, Inc.
Product Code	NUJ · General, Plastic Surgery
Decision Date	Jul 20, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Device Story

Reprocessed single-use bipolar electrosurgical instrument; used in open and minimally invasive surgery. Input: RF energy from compatible Covidien electrosurgical generators (ForceTriad). Operation: Hand-actuated lever opens/closes jaws; latching mechanism holds tissue; RF energy seals and divides vessels/tissue bundles/lymphatics. Output: Sealed and divided tissue. Used by surgeons in OR. Benefits: Hemostasis and tissue division. Device is reprocessed version of original Covidien LigaSure models (LF1623, LF1637).

Clinical Evidence

Bench testing only. No clinical data. Performance testing included electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2), simulated use, device integrity, thermal analysis, burst pressure, histopathology, seal quality, tissue sticking, cleaning validation, biocompatibility (sensitization, irritation, pyrogenicity, acute systemic toxicity), sterilization validation, and product stability.

Technological Characteristics

Bipolar electrosurgical instrument; RF energy source. Models: LF1623 (5 mm x 23 cm), LF1637 (5 mm x 37 cm). Hand-actuated lever with latching mechanism. Reprocessed single-use device. Compatible with ForceTriad electrosurgical generators (SW v.3.50/3.60+).

Indications for Use

Indicated for use in general, urologic, vascular, thoracic, and gynecologic surgery for ligation and division of vessels (up to 7 mm), tissue bundles, and lymphatics. Contraindicated for tubal coagulation for sterilization.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

LigaSure Blunt Tip Sealer/Divider (K142929)

Reference Devices

LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip Sealer/Divider, Maryland Jaw One Step Sealer/Divider, curved (K141153)
ForceTriad generator (K070162)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 20, 2016 Surgical Instrument Service And Savings Inc. Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756 Re: K160333 Trade/Device Name: Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NUJ Dated: June 17, 2016 Received: June 20, 2016 Dear Ms. Panteleon: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Christopher J. Ronk -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Page 3 - Ms. Brandi Panteleon Reprocessed Single-Use Device Models Included in Clearance: | Device Model | Device Name | Original Manufacturer | |--------------|------------------------------------------------------------------|--------------------------| | LF1623 | LigaSure Blunt Tip Open Sealer/Divider (5 mm x 23 cm) | Covidien | | LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider (5 mm x 37 cm) | Covidien | {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160333 Device Name Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider #### Indications for Use (Describe) The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vesses, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on veins) up to and including 7 mm. It is indicated for use in general surgery and such specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures. ### Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Reprocessed Single-Use Device Models Included in Clearance: | Device Model | Device Name | Original Manufacturer | |--------------|------------------------------------------------------------------|--------------------------| | LF1623 | LigaSure Blunt Tip Open Sealer/Divider (5 mm x 23 cm) | Covidien | | LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider (5 mm x 37 cm) | Covidien | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star to the right of it. To the right of the Medline logo is the word "Renewal", with "Re" in green and "Newal" in blue. Underneath the word "Renewal" is the phrase "Full Circle Reprocessing" in blue. # Summary K160333 | Submitter/ Owner | Medline ReNewal 2747 SW 6th St. Redmond, OR 97756 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name | Brandi Panteleon Director, Quality Assurance and Regulatory Affairs P: 541-923-3310 F: 541-923-3375 E: bpanteleon@medline.com | | Prepared by | Stephanie Boyle Mays Regulatory Affairs Specialist, Regulatory Affairs P: 541-516-4205 F: 541-516-4180 E: smays@medline.com | | Date Prepared | February 3, 2015 | | Device Names | Proprietary Name: Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider Common Name: Bipolar electrosurgical instrument | | Classification | Electrosurgical cutting and coagulation device and accessories Product code: NUJ Class: Class II, non-exempt | | Predicate Device | K142929 LigaSure Blunt Tip Sealer/Divider | | Reference Device | K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip Sealer/Divider, Maryland Jaw One Step Sealer/Divider, curved | | Device Models | LF1623 and LF1637 | | Device Description | The Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider (LF1623, LF1637) devices are sterile single-use, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics clamped between the jaws, grasping tissue and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. A hand-actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not include software. | | Intended Use | The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on | | vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures. | | | Technological Characteristics | The technological characteristics and the fundamental scientific technology of the subject devices are identical to the predicate and reference devices. The proposed devices are reprocessed versions of the predicate and reference devices. | | Performance Testing | The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests: electrical safety and electromagnetic compatibility in accordance with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2; simulated use; device integrity; blade trigger advance/return; shaft knob rotation; device recognition; thermal analysis characterization; handle locking; burst pressure; histopathology; seal quality; tissue sticking;. cleaning; protein and carbohydrates; biocompatibility; sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. | | Conclusion | Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate and reference devices, Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Dividers (LF1623 and LF1637) are substantially equivalent to the predicate. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is in green and blue, and the words "Full Circle Reprocessing" are below the Renewal logo. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a large, bold font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it. | Device Characteristics | Predicate | Proposed | Reference Device | Comparison | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Covidien LigaSure Blunt Tip Sealer/Divider | Medline ReNewal LigaSure Blunt Tip Sealer/Divider | Covidien LigaSure 5-mm Blunt Tip Laparoscopic Sealer/Dividera | Same devices; different manufacturer | | Predicate 510(k) | K142929 | K160333 | K141153 | N/Ab | | Model Numbers | LF1623 | LF1623, LF1637 | LF1637 | N/A | | Device Description | The Covidien LigaSure Blunt Tip Sealer/Divider (LF1623, LF1644) devices are sterile single-use, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundels and lymphatics clamped between the jaws, grasping tissue and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy A hand-actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed | The Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider (LF1623, LF1637) devices are sterile single-use, hand-held bipolar vessel sealing device is designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics clamped between the jaws, grasping tissue and blunt dissection during open and minimally invasive general surgical procedures (as indicate) using radio frequency (RF) energy. A hand-actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position | Same as predicate | • K142929 (predicate) and proposed devices include open and laparoscopic blunt tip sealer/dividers. • K141153 (reference) and proposed devices specify use of the ForceTriad energy system. The ForceTriad system is a Covidien electrosurgical generator that is included in the K142929 description. | #### Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a large, bold font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it. | Device Characteristics | Predicate | Proposed | Reference Device | Comparison | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Covidien LigaSure Blunt Tip Sealer/Divider | Medline ReNewal LigaSure Blunt Tip Sealer/Divider | Covidien LigaSure 5-mm Blunt Tip Laparoscopic Sealer/Divider | Same devices; different manufacturer | | Device Description (concluded) | position during vessel sealing and cutting. The proposed devices do not include software. | during vessel sealing and cutting. The proposed devices do not include software. | (as stated previously) | · All devices are LigaSure blunt-tip sealer/dividers | | Indications for Use (IFU) | The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and surgery specialties as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. | The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. | Same as predicate | Indications for use for the K142929 predicate LigaSure Sealer/Divider and the proposed devices are the same. The IFU for K142929 includes both the LF1623 and LF1637 in the instructions that accompany the devices. | #### Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart (continued). (continued) {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The logo features the Medline logo on the left, which is a blue stylized star. To the right of the Medline logo is the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font. #### Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart (concluded). Table 1: | Device Characteristics | Predicate | Proposed | Reference Device | Comparison | |----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------| | | Covidien LigaSure Blunt Tip Sealer/Divider | Medline ReNewal LigaSure Blunt Tip Sealer/Divider | Covidien LigaSure 5-mm Blunt Tip Laparoscopic Sealer/Divider | Same devices; different manufacturer | | Indications for Use (concluded) | The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedure. | The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures. | (as stated previously) | (as stated previously) | | Power Platform | ForceTriad SW v.3.60 or higher for LF1623 ForceTriad SW v. 3.50 or higher for LF1637° | ForceTriad SW v.3.60 or higher for LF1623 ForceTriad SW v. 3.50 or higher for LF 1637 | ForceTriad SW v. 3.50 or higher for LF1637 | Same | | Technological Characteristics | The only differences between the predicate and subject devices are the length of the shaft. Note: predicate device for K142929 is reference device K141153 | The technological characteristics and the fundamental scientific technology of the subject devices are identical to the predicate and reference devices. The proposed devices are a reprocessed version of the predicate and reference devices. | Same as predicate. | Same | | a Only the LigaSure 5 mm Blunt Tip Sealer/Divider is included in this submission from reference device K141153. Medline ReNewal is not | | | | | including the LigaSure Curved Small Jaw Sealer/Divider of the Maryland Jaw One Step Sealer/Dividers in this submission. b N/A = not applicable. C ForceTriad generator was cleared under K070162: It will not be reprocessed, and it is not part of this submission.

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!