← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K963184

# OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM (K963184)

_Olympus America, Inc. · GCJ · Dec 31, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K963184

## Device Facts

- **Applicant:** Olympus America, Inc.
- **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md)
- **Decision Date:** Dec 31, 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 Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.

## Device Story

Endoscopic system for vessel harvesting; includes endoscope, hand instruments, and accessories. Used for subcutaneous/subfacial access, ligation, and harvesting of vessels (veins, arteries, ducts, nerves) in lower extremities. Operated by surgeons in surgical settings. Provides visualization and mechanical manipulation for minimally invasive harvesting procedures; facilitates vessel access through small incisions; reduces surgical trauma compared to open procedures.

## Technological Characteristics

Endoscopic system comprising endoscope and hand instruments for subcutaneous dissection and vessel harvesting. Mechanical/optical device; no electronic or software components described.

## 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

- Olympus Endoscopes for Subcutaneous Dissection/Rejection in Plastic/Reconstructive Surgery and Aesthetic Surgery ([K950076](/device/K950076.md))
- Olympus Hand Instruments for Subcutaneous Dissection/Rejection in Plastic/Reconstructive Surgery and Aesthetic Surgery ([K950103](/device/K950103.md))
- Ethicon EndoSurgery Hand Retractors, Dissectors for Vessel Harvesting ([K955120](/device/K955120.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.
>
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DEC 31 1996 K96 3/84

# 510(k) SUMMARY

## OLYMPUS ENDOSCOPIC SYSTEM FOR VESSEL HARVESTING

|  Device Name: | Olympus Endoscopic System for Vessel Harvesting: endoscope, associated accessories and ancillary equipment.  |
| --- | --- |
|  Common/Usual Name: | Olympus Endoscopic System for Vessel Harvesting  |
|  Classification Name: | Endoscope and Accessories  |
|  Predicate Devices: | Olympus Endoscopes for Subcutaneous Dissection/Rejection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950076); Olympus Hand Instruments for Subcutaneous Dissection/Rejection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950103); Ethicon EndoSurgery Hand Retractors, Dissectors for Vessel Harvesting (K955120). Refer to Subsection I-A for additional list of predicate devices.  |
|  Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5474  |
|  Summary Preparation Date: | March 29, 1996  |

## Statement of Intended Use

The Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.

## Comparison to Predicate Device

The Endoscopic Vessel Harvesting System is identical or similar in design, function, and intended use to the Olympus Endoscopes for Subcutaneous Dissection/Rejection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950076), Olympus Hand Instruments for Subcutaneous Dissection/Rejection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950103), and Ethicon EndoSurgery Hand Retractors, Dissectors for Vessel Harvesting (K955120). Thus, when compared to the predicate devices, the Olympus System for Vessel Harvesting does not raise any questions regarding the safety of the subject device.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K963184](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K963184)

**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).

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