Who is the manufacturer of REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS?

Clearmedical, Inc. filed the 510(k) submission for REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (K033578).

What is the FDA product code for REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS?

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

What is the regulatory pathway for REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS?

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

What are the predicate devices for REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS?

Endopath and Proximate Linear Cutters and Staplers (K020779).

Who can help prepare an FDA 510(k) submission like REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS?

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.

REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS

K033578 · Clearmedical, Inc. · NLL · Jul 11, 2005 · General, Plastic Surgery

Device Facts

Record ID	K033578
Device Name	REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
Applicant	Clearmedical, Inc.
Product Code	NLL · General, Plastic Surgery
Decision Date	Jul 11, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4750
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery. The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.

Device Story

Reprocessed reloadable linear cutters and staplers; used for tissue transection, resection, and anastomosis creation. Device delivers two double-staggered rows of titanium staples while dividing tissue between rows. Reloadable during single procedure up to manufacturer-specified maximum firings. Used in OR by surgeons. Reprocessing involves cleaning, inspection, testing, packaging, and sterilization of previously used devices for additional single-patient use. Output is mechanical tissue approximation and division; assists surgeons in surgical procedures; benefits patients by enabling standard surgical stapling techniques.

Clinical Evidence

Bench testing only. Validation of cleaning, performance, packaging, and sterilization, along with biocompatibility testing, demonstrate the reprocessed devices perform as intended and are safe and effective.

Technological Characteristics

Manual surgical instruments. Materials: titanium staples. Function: delivers two double-staggered rows of staples with tissue division. Reprocessed from previously used devices. Sterilization: validated process for single-patient reuse. No software or electronic components.

Indications for Use

Indicated for patients undergoing gastrointestinal, gynecologic, thoracic, or pediatric surgery requiring tissue transection, resection, or anastomosis creation.

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

Endopath and Proximate Linear Cutters and Staplers (K020779)

Related Devices

K183435 — Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black · Ethicon Endo-Surgery, LLC · Feb 6, 2019
K070859 — REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS · Sterilmed, Inc. · Sep 12, 2007
K070930 — REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS · Sterilmed, Inc. · Oct 18, 2007
K162707 — Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload · Golden Stapler Surgical Co., Ltd. · Jul 14, 2017
K161757 — Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads · Victor Medical Instruments Co., Ltd. · Dec 5, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ KO33579 ## JUL 1 ] 2005 ## 510(k) Summary : | Submitter: | ClearMedical, Inc. 1776 136th Place NE Bellevue, WA 98005 | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Gene Lim Ph: (425) 460-2779 Fax: (425) 401-1515 | | Date: | June 21, 2005 | | Trade name: | ClearMedical Reprocessed Reloadable Linear Cutters and Staplers | | Common name: | Reloadable Linear Cutters and Linear Staplers | | Classification name: | Manual surgical instrument for general use (21 CFR 878.4800) | | Product code: | GCJ - Laparoscope, General & Plastic Surgery | | Predicate device: | K020779 - Endopath and Proximate Linear Cutters and Staplers | | Device description: | The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert. The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert. | | Intended use: | The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery. The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery. | | Technological characteristics: | Reprocessed reloadable cutters and staplers are used devices that are cleaned, inspected, tested, packaged, and sterilized for an additional single patient use. The technological characteristics of design, material, and functional performance of reprocessed reloadable cutters and staplers are unchanged and remain equivalent to the predicate devices. | | Test data: | Validation of cleaning, performance, packaging, and sterilization together with biocompatibility testing demonstrate reprocessed clip reloadable cutters and staplers perform as intended and are safe and effective. | | Conclusion: | Based on information provided in this submission, ClearMedical Reprocessed Reloadable Cutters and Staplers are substantially equivalent to the identified predicate devices and are safe and effective for their intended use. | {1}------------------------------------------------ : . {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 1 2005 Clear Medical Incorporated Mr. Mike Kovacs 1776 136th Place Northeast Bellevue, Washington 98005 Re: K033578 K033578 Trade/Device Name: Reprocessed Reloadable Cutters, Staplers, and Appliers Models, Reprocessed Reloadable Cattle, Success, Success, Proximate Linear Staplers TL30, TL60, TX30B, and TX60B Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: May 27, 2005 Received: May 31, 2005 Dear Mr. Kovacs: We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 210(x) premained is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced anove and nave decimined the devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manced provice andical Device Ameridae, or to commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance approval application (PMA).) and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosmetic Act (Act) that to not require approvial controls provisions of the Act. The You may, therefore, market the device, subject to the general controls provisions o You may, therefore, market the device, subject or as general registration, listing of general controls provisions of the Act include requirements for annual registration, lis general controls provisions of the Fee merator seat prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into entrols. Existins major regulations affecting your device it may be subject to such additional controls. Existing may on and it may be subject to such additional controll. "Entroling 21, Parts 800 to 898. In addition, FDA can be found in the Code of Federal Regardies) 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 Please be advised that FDA s issualio of a studential with other requirements of the Act that FDA has made a determination that your device complies with on your that FDA has made a decisimilation that Jour assess of by other Federal agencies. You must of any Pederal Statutes and regulations daminities on of limited to: registration and issting (21 l comply with all the Act S requirements, mercesses on annufacturing practice requirements as set CPR Part 807), labeling (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (QD) regalistics (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 – Mr. Mike Kovacs This letter will allow you to begin marketing your device as described in your Section 510(k) The are and the support of a line of a location to tiel assivelence of your devi This letter will allow you to begin maketing your active of your device of your device to a legally premarket notification. The FDA finding of substantial equive and thus, p premarket notification. The IDA Inding of substanted organ 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 rs (11) 11 (11) 11 (11) 111 (11) 176 0115 - Alge - places note the regulat If you desire specific advice for your device on our labeling news note ( contact the Office of Compliance at (240) 276-0115 . Also, please note (2010) . You may obtain contact the Office of Compliance at (240) 270 - 1780, p. Part 807.97). You may obtain "Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket noutheadon" (1 on the Division of Small other general information on your responsibilities under the Act from the Division of Small other general information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its toll-free wares/cuppo Manufacturers, International and Consumer 71ssistance as tos vol. Industry/support/index.html. Sincerely yours, iriam C. Provost Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K033578 \$ Device Name: Reprocessed Reloadable Cutters and Staplers Indications for Use: Reloadable Cutters The ClearMedical Reprocessed Reloadable Cutters are intended for transection, The ClearMedical Reprocessed Reloadable Cuttors and a resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery. Reloadable Staplers The ClearMedical Reprocessed Reloadable Staplers are intended for the resection THE Cleariviculed! Represent and in thoracic surgery. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ( ) THE SE DO NOT WRITE BELOW (FANSED) IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Device 510(k) Number K033578