← Product Code [OCW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW) · K963999 # AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE (K963999) _United States Surgical, A Division of Tyco Healthc · OCW · Nov 27, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K963999 ## Device Facts - **Applicant:** United States Surgical, A Division of Tyco Healthc - **Product Code:** [OCW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW.md) - **Decision Date:** Nov 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures. ## Device Story Disposable, sterile endoscopic stapling device; used for affixing prosthetic material or approximating tissue; operated by surgeons in endoscopic or open procedures; provides fastener security; mechanical operation. ## Clinical Evidence Bench testing only; in-vivo and in-vitro testing performed to evaluate fastener security; results demonstrate adequate fastener strength. ## Technological Characteristics Disposable endoscopic stapler; materials compliant with ISO 10993-1; mechanical actuation; sterile. ## 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 - Origin® Tacker™ System ([K944415](/device/K944415.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} United States Surgical Corporation 510(k) Premarket Notification AUTO SUTURE* Modified Endoscopic Fascia Stapler** K963999 # SUMMARY 510(K) SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS SUBMITTER: United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 NOV 27 1996 CONTACT PERSON: Christopher Taylor DATE PREPARED: October 4, 1996 CLASSIFICATION NAME: Implantable Staple COMMON NAME: Surgical Staple PROPRIETARY NAME: Trademark name not yet determined. PREDICATE DEVICE: Origin® Tacker™ System (K944415) DEVICE DESCRIPTION: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is an endoscopic stapling device. The device is disposable and is supplied sterile. INTENDED USE: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures. MATERIALS: All component materials of the AUTO SUTURE* Modified Endoscopic Fascia Stapler** device are comprised of materials which are in accordance with ISO Standard #10993-1. PERFORMANCE: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device was tested both in-vivo and in-vitro to evaluate fastener security. The results of this testing demonstrate that the subject device provides adequate fastener strength. * Trademark of United States Surgical Corporation ** Trademark name not yet determined --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K963999](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K963999) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com