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Olympus Subcutaneous Endoscopy System

by Olympus America, Inc.

510(k) K963184

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963184 Date31 Dec 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Olympus Subcutaneous Endoscopy System is a medical device designed for endoscopically gaining access to subcutaneous areas. It is intended for use in procedures requiring visualization and intervention within the subcutaneous tissue.

The system is manufactured by Olympus America, Inc. and is supplied as a single-use device. It is not MRI compatible and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with product code GCJ.

Other devices from Olympus America, Inc.

See all devices from Olympus America, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Olympus Subcutaneous Endoscopy System used for?

    The Olympus Subcutaneous Endoscopy System is designed for endoscopically gaining access to subcutaneous areas, providing visualization and intervention capabilities within subcutaneous tissue during medical procedures.

  • Is the Olympus Subcutaneous Endoscopy System reusable?

    No, the Olympus Subcutaneous Endoscopy System is supplied as a single-use device and should not be reused according to the manufacturer's instructions.

  • What are the storage requirements for the Olympus Subcutaneous Endoscopy System?

    The device should be stored according to the manufacturer's instructions, though specific storage conditions are not detailed in the provided information.

  • Is the Olympus Subcutaneous Endoscopy System MRI compatible?

    No, the Olympus Subcutaneous Endoscopy System is not MRI compatible and should not be used in MRI environments.

  • What regulatory clearance has the Olympus Subcutaneous Endoscopy System received?

    The Olympus Subcutaneous Endoscopy System has received FDA 510(k) clearance with product code GCJ, which was determined to be substantially equivalent to other devices in this category.