← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K980022 # ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) (K980022) _Ethicon Endo-Surgery, Inc. · GCJ · Mar 9, 1998 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K980022 ## Device Facts - **Applicant:** Ethicon Endo-Surgery, Inc. - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Mar 9, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches. ## Device Story Manual surgical instrument for endoscopic soft tissue approximation; facilitates placement of interrupted stitches; used in minimally invasive surgery; operated by surgeons; provides mechanical fastening of soft tissue. ## Clinical Evidence No clinical data provided; device is identical to previously cleared predicate. ## Technological Characteristics Manual surgical instrument; design and materials unchanged from predicate K972679. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Predicate Devices - ENDOPATH® Endoscopic Tissue Fastening System (ETFS) ([K972679](/device/K972679.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ETHICON ENDO-SURGERY, INC. company ## 980022 | 4545 CREEK ROAD
CINCINNATI, OH 45242-2839 | 510(k) Summary of Safety and Effectiveness | MAR - 9 | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Contact | Lorri Chavez, Project Manager
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242
Telephone: (513) 483-3513 | | | Date | January 2, 1998 | | | Device | Name: ENDOPATH® Endoscopic Tissue Fastening System (ETFS)
Classification Name: Manual Surgical Instrument
Common Name: Knot Tying Instrument
Trade Name/Proprietary Name: ENDOPATH® Endoscopic Tissue Fastening
System (ETFS) | | | Legally
marketed
device | ENDOPATH® Endoscopic Tissue Fastening System (ETFS) (K972679). | | | Device
description | All device functions, scientific concepts, significant physical and performance
characteristics (i.e. device design, materials, physical properties, etc.) have not
changed in design or manufacture from 510(k) #972679. | | | Intended use | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended
for use where soft tissue is being approximated. | | | Indications
statement | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) indication
statement has not changed from 510(k) #972679. | | | Technological
characteristics | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS)
technological characteristics have not changed from 510(k) #972679. | | | Performance
data | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS)
performance has not changed from 510(k) #972679. | | ext page {1}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness, Continued : ﻨﻴﺔ ﺍﻟﺘﺴﻴﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ ETHICON ENDO-SURGERY, INC. New Contraindication for the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) . . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 9 1000 Ms. Lorri Chavez · Project Manager Requlatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839 K980022 Re: Trade Name: ENDOPATH® Endoscopic Tissue Fasteninq System (ETFS) Regulatory Class: II Product Code: GCJ and GAT Dated: January 2, 1998 Received: January 5, 1998 Dear Ms. Chavez: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), 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 895. ಕ್ಕೆ substantially equivalent determination assumes compliance with================================================================================================================ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Ms. Chavez This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Scalef ☑ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Derig Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement (App. B) Statement Indications for Use Statement: 510(k) Number: K 980022 Device Name: ENDOPATH® Endoscopic Tissue Fastening System (ETFS) The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches. ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Prescription Use (Per 21 CFR 801.109) X bicolezo General Restorative Device ETHICON ENDO-SURGERY, INC. New Contraindication for the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K980022](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K980022) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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