SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS

Q: Who is the manufacturer of SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS?

Power Medical Interventions, Inc. filed the 510(k) submission for SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS (K030653).

Q: What is the FDA product code for SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS?

GDW. It is classified under 21 CFR 878.4750 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS?

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

Q: Who can help prepare an FDA 510(k) submission like SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS?

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.

K030653 · Power Medical Interventions, Inc. · GDW · Mar 31, 2003 · General, Plastic Surgery

Device Facts

Record ID	K030653
Device Name	SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
Applicant	Power Medical Interventions, Inc.
Product Code	GDW · General, Plastic Surgery
Decision Date	Mar 31, 2003
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4750
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Device Story

SurgASSIST™ Straight Linear Stapler and 4-Row No-Knife Digital Loading Units (DLUs) are single-patient-use surgical staplers. The device consists of a DLU attached to a flexible shaft (FlexShaft) connected to a Power Console (PC). The surgeon operates the device via a handheld electronic Remote Control Unit (RCU). The DLU features an anvil and staple cartridge that compresses tissue, forms staples, and (in stapler models) cuts tissue. The device is used in general and endoscopic surgery to secure tissue layers. Each DLU/Reload contains an electronic memory module that identifies the component type and prevents reuse of fired cartridges. The system provides mechanical power for stapling and cutting, allowing the surgeon to adjust the DLU attitude for optimal access. The output is a stapled (and optionally cut) tissue line, facilitating resection and anastomosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium staples. Energy: Mechanical power via Power Console. Connectivity: Electronic memory module in DLU for identification and reuse prevention. Sterilization: Ethylene Oxide (ETO). Form factor: 15mm diameter DLU, axial to FlexShaft. Software: Embedded firmware for DLU identification and lockout.

Indications for Use

Indicated for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic procedures requiring resection, transection, and creation of anastomoses. Contraindicated for tissue requiring excessive force to compress to specified heights (1.2mm-2.0mm) or tissue that compresses easily below these heights.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

SurgASSIST™ System with Straight Linear Cutter Digital Loading Units® (K020719)
Endopath ETS Flex45 No-Knife Articulating Linear Stapler (K020779)

Related Devices

K022313 — SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V · Power Medical Interventions, Inc. · Dec 9, 2002
K021701 — SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 · Power Medical Interventions, Inc. · Jun 21, 2002
K020719 — SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES · Power Medical Interventions, Inc. · May 10, 2002
K183435 — Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black · Ethicon Endo-Surgery, LLC · Feb 6, 2019
K221013 — GIA Auto Suture Stapler with DST Series Technology · Covidien · May 5, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ K030653 (1 of 7) MAR 3 1 2003 ## Special 510(k) Device Modification PREMARKET NOTIFICATION SAFETY AND EFFECTIVENESS SUMMARY # SurgASSIST Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads In Accordance with 21 CFR section 807.92 Power Medical Interventions, Inc., is submitting the following safety and effectiveness summary. - 1) Submitter Information: Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax Applicant: Barbara J. Whitman Date of Notification: February 28, 2003 - 2) Name of Device: | Trade Name: | SurgASSIST™ Straight Linear Stapler DLU with Reloads and Straight Linear 4 Row No Knife DLU with Reloads | |--------------|----------------------------------------------------------------------------------------------------------------------| | Common Name: | Linear Stapler with Implantable Staples and Reloads | Classification Name: Staple, Implantable, GDW - 3) Predicate Devices: - A. SurgASSIST™ System with Straight Linear Cutter Digital Loading Units®, 55mm and 30mm with Blue and Green Reloads, with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF SLC55B, SLC55G, SLCR55B, SLCR55G, SLC30B, SLC30G, SLCR30B, SLCR30G. (K020719). # 000014 {1}------------------------------------------------ 030653 (P.2 of 7) - B. Endopath ETS Flex45 No-Knife Articulating Linear Stapler, Ethicon Endo-Surgery, Inc., Cincinnati, OH. REF NAB, NAG. (K020779). - 4) Device Description: The devices described here are reloadable Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. All have a maximum diameter of .596" and can be used within a 15 mm cannula. The DLUs are supplied pre-sterilized and ready for use upon removal from their packaging. Reloadable stapling and cutting cartridges are referred to as "Reloads". Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position layers of tissue in readiness for stapling and cutting. At the same time, the anvil provides support and a means for correctly forming staples while they are closed sequentially along the tissue, followed by the cutting blade, when included. The 15 mm diameter DLUs are axial to the FlexShaft, forming a straight extension to the FlexShaft, to which they are connected. Loaded Straight Linear Stapler and Straight Linear 4 Row No Knife DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together. Straight Linear Stapler and Straight Linear 4 Row No Knife Reloads contain staples and the means to sequentially force staples toward the anvil. The cutting blade, when included, is advanced immediately behind the staple pushers so that tissue is sequentially stapled and then cut, proceeding from one end of the cartridge to the other. Straight Linear Stapler DLUs, 55 mm with Blue and Green Reloads have 2 staggered rows of staples on one side of the cutter, coded Blue (1.2 mm) for normal tissue and Green (2.0 mm) for thick tissue. DLUs are available with Blue or Green Reloads installed. Individual Blue and Green Reloads are available. Straight Linear 4 Row No Knife DLUs, 55 mm with Gray Reloads have two, double-staggered rows of staples, coded Gray (1.2 mm) for normal tissue (same as 55 mm Blue Straight Linear Cutter without the blade). DLUs are available with Gray cartridges installed. "No Knife" distinctively labeled. Individual Gray Reloads are available. The DLUs are attached to the end of the flexible shaft assembly that contains a pair of flexible rotary drive shafts within an overall flexible tube called the FlexShaft, hereafter referred to as FS. The other end of the FS is connected to a Power Console (PC), which applies mechanical power to the drive shafts. {2}------------------------------------------------ DLUs have all functions powered by the PC. The FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility. The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU) that is plugged into the front panel of the PC. The DLUs have quick attach and release means of coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS, is rotated by hand. DLU designs allow for attachment of Reloads, but will inhibit attachment of incompatible Reloads. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used and prevents a used Reload from being refired. - 5) Indications For Use The SuraASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. - 6) Comparison to Predicate Devices The following table compares the subject Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads to the previously cleared predicate Straight Linear Cutter Digital Loading Units® with Reloads (K020719). {3}------------------------------------------------ Pow. Medical Interventions, Inc. SurgASSIST™ Straight Linear Stapler DLUs with Reloads Special 510(k) Device Modification PreMarket Notification, February 28, 20 Straight Linear Stapler DLU Product Features Comparison Cha | Features & Description | Name | Predicate | Predicate | Features & Description | Predicate | Predicate | | |-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | SurgASSIST™ Straight Linear Stapler, 55 mm With Blue and Green Reloads and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) | SurgASSIST™ Straight Linear Stapler DLUs, 55 mm with Blue and Green Reloads and Straight Linear 4 Row No Knife DLUs | SurgASSIST™ Straight Linear Cutter DLUs, 55 mm and 30 mm with Blue and Green Reloads | Ethicon Endo-Surgery, Inc. Endopath ETS Flex45 No-Knife Articulating Linear Stapler | SurgASSISTTM Straight Linear Stapler, 55 mm With Blue and Green Reloads and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) | SurgASSISTTM Straight Linear Cutter DLUs, 55 mm and 30 mm with Blue and Green Reloads | Ethicon Endo-Surgery, Inc. Endopath ETS Flex45 No-Knife Articulating Linear Stapler | | | | | SurgASSIST™ Straight Linear Cutter DLUs, 55 mm and 30 mm with Blue and Green Reloads | Endopath ETS Flex45 No-Knife Articulating Linear Stapler | Do not use the SurgASSISTTM Straight Linear Stapler DLU, 55mm Blue, on any tissue that requires excessive force to compress to 1.5 mm or on any tissue that compresses easily below 1.5 mm. Do not use the SurgASSISTTM Straight Linear Stapler DLU, 55 mm Green, on any tissue that requires excessive force to compress to 2.3 mm or on any tissue that compresses easily below 2.3 mm. Do not use the SurgASSISTTM Straight Linear 4 Row No Knife DLU, (Gray), on any tissue that requires excessive force to compress to 1.5 mm or on any tissue that compresses easily below 1.5 mm. | Do not use the SurgASSISTTM System Straight Linear Cutter DLU, 55 mm, 30 mm where combined tissue thickness exceeds 2.3 mm or is less than 1.0 mm. | Do not use the instrument with blue reload on any tissue that requires excessive force to compress to 1.5 mm or on any tissue that compresses easily to below 1.5 mm. Do not use on ischemic or necrotic tissue. Do not use the instruments on the aorta. Do not use any linear cutter on major vessels without making provision for proximal and distal control. Do not use the instrument on solidorgans, such as liver or spleen, where attempted compression would be destructive. These instruments are not intended for use when surgical stapling is contraindicated. Do not use the instruments with green reload on any tissue that requires excessive force to compress to 2.0 mm or on any tissue that compresses easily to below 2.0 mm. | | | Manufacturer of Record | Power Medical Interventions, Inc. | Power Medical Interventions, Inc. | Ethicon Endo-Surgery, Inc | FDA Class (System) | | | | | Contract Manufacturer | The MedTech Group South Plainfield, NJ | The MedTech Group South Plainfield, NJ | Ethicon Endo-Surgery, Inc | Number of Staples | SLS55B, SLSR55B - 28 staples SLS55G, SLSR55G - 28 staples SLS55B4, SLSR55B4 - 56 staples | SLC55B, SLCR55B - 56 staples SLC55G, SLCR55G - 56 staples SLC30B, SLCR30B - 32 staples SLC30G, SLCR30G - 32 staples | NAB - 44 staples NAG - 44 staples | | 510(k) Clearance Numbers | Subject of this Notification | K020719 | K020779 | | | | | | Product Codes | SLS55B, SLSR55B, SLS55G, SLSR55G, SLS55B4, SLSR55B4 | SLC55B, SLCR55B, SLC55G, SLCR55G, SLC30B, SLCR30B, SLC30G, SLCR30G | NAB45 and NAG45 | | | | | | Intended use | Have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. | Have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. | Intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium. | | | | | K 030653 (P.4 of 7) 000017 {4}------------------------------------------------ Pow. Medical Interventions, Inc. SurgASSIST™ Straight Linear Stapler DLUs with Reloads Special 510(k) Device Modification PreMarket Notification, February 28, 2 # Straight Linear Stapler DLU Product Features Comparison Cham K030653 (P.Sofm) {5}------------------------------------------------ Pow.. Medical Interventions, Inc. SurgASSIST™ Straight Linear Stapler DLUs with Reloads Special 510(k) Device Modification PreMarket Notification, February 28, 20 # raight Linear Stapler DLU Product Features Comparison Cham | Features & Description | SurgASSIST™ Straight Linear Stapler, 55 mm With Blue and Green Reloads and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) | Predicate SurgASSIST™ Straight Linear Cutter DLUs, 55 mm and 30 mm with Blue and Green Reloads | Predicate Ethicon Endo-Surgery, Inc. Endopath ETS Flex45 No-Knife Articulating Linear Stapler | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Rows of Staples | SLS55B, SLSR55B - 2 rows SLS55G, SLSR55G - 2 rows SLS55B4, SLSR55B4 - 4 rows | SLC55B, SLCR55B - 4 rows SLC55G, SLCR55G - 4 rows SLC30B, SLCR30B - 4 rows SLC30G, SLCR30G - 4 rows | NAB - 4 rows NAG - 4 rows | | Knife/Scalpel | SLS55B, SLSR55B - scalpel included SLS55G, SLSR55G - scalpel included SLS55B4, SLSR55B4 - NO KNIFE | SLC55B, SLCR55B - scalpel included SLC55G, SLCR55G - scalpel included SLC30B, SLCR30B - scalpel included SLC30G, SLCR30G - scalpel included | NAB - NO KNIFE NAG - NO KNIFE | | Staple Diameter | SLS55B, SLSR55B - .21 mm SLS55G, SLSR55G - .23 mm SLS55B4 - .21 mm | SLC55B, SLCR55B - .21 mm SLC55G, SLCR55G - .23 mm SLC30B, SLCR30B - .23 mm SLC30G, SLCR30G - .23 mm | NAB - .23 mm NAG - .23 mm | | Staple Height | SLS55B, SLSR55B - 1.2 mm SLS55G, SLSR55G - 2.0 mm SLS55B4 - 1.2 mm | SLC55B, SLCR55B - 1.2 mm SLC55G, SLCR55G - 2.0 mm SLC30B, SLCR30B - 1.2 mm SLC30G, SLCR30G - 2.0 mm | NAB - 1.5 mm NAG - 2.0 mm | | DLU Internal Power | None | None | None | | Digital Information | Memory module containing digital data for identification, etc. | Memory module containing digital data for identification, etc. | None | | How Supplied | Sterile - Single Patient Use | Sterile - Single Patient Use | Sterile - Single Patient Use | # 000019 03d6S3(f.6of7) {6}------------------------------------------------ Pow # traight Linear Stapler DLU Product Features Comparison Cha (continued from continued from previous page) | 1 1 | | | |--------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | t 1 | | | | 1 | | | | | | | | | | | | | | | | | | | | 1 | | | | | | | | 1 | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | | | ) | | | | | | | | | | | | | | | | 1 | | | | | | | | | | | | | | | | | | | | . | | | | | | | | | | | | | | | | | | | | Features & Description | Method of Sterilization | Digital Loading Unit® | Reloads | |------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------|-----------------------------| | SurgASSIST™™ Straight Linear Stapler, 55 mm with Blue and Green Reloads and Straight Linear 4 Row No Knife Digital Loading Units® (DLUS) | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | Tyvek Pouch | | Predicate SurgASSIST™™ Straight Linear Cutter DLUs, 55 mm and 30 mm with Blue and Green Reloads | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | Tyvek Pouch | | Predicate Ethicon Endo-Surgery, Inc. Endopath ETS Flex45 No-Knife Articulating Linear Stapler | Irradiation | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid | Image /page/6/Picture/5 description: The image contains handwritten text that appears to be an alphanumeric code or identifier. The text reads "KU30653(F.70P7)". The characters are written in a cursive style, and the text is slightly slanted. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR 3 1 2003 Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938 Re: K030653 Trade/Device Name: SurgASSIST™ Straight Linear Stapler Digital Loading Unit® with Reloads and Straight Linear 4 Row No Knife Digital Loading Unit® with Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: February 28, 2003 Received: March 3, 2003 Dear Ms. Whitman: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {8}------------------------------------------------ Page 2 - Ms. Barbara J. Whitman This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost (Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Power Medical Interventions, Inc. New Hope, PA 18938 510(k) No. K K934653 Device Name: SurgASSIST™ Straight Linear Stapler Digital Loading Unit® with Reloads And Straight Linear 4 Row No Knife Digital Loading Unit® with Reloads ### INDICATIONS FOR USE: The SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use Per 21CFR §801.109 Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Miriam C. Phrost (Division Sign-Off) Division of General, Restorative and Neurological Devices OR 510(k) Number_________________________________________________________________________________________________________________________________________________________________ 000012