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Olympus KD-6G1-9Q Wire Guided Papillotomu Knife

by Olympus America, Inc.

510(k) K950166

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 ongoing

This device is named in the recall

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 NumberK950166 Date22 Feb 1995ClearedStatusActive

Recalls

10 recalls · 10 ongoing · FDA

  • 10 recalls, same reason

    • Ongoing Z-1293-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1290-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1288-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1287-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1289-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1296-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1295-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1292-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1291-2026 FDA Class II initiated 7 Jan 2026
    • Ongoing Z-1294-2026 FDA Class II initiated 7 Jan 2026

    Devices which did not undergo thermoforming could deform and lose performance.

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  • Withdrawn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
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 KD-6G1-9Q Wire Guided Papillotomu Knife is an electrosurgical endoscopic unit designed for use in medical procedures. It is classified as a Unit, Electrosurgical, Endoscopic device with or without accessories.

This device is manufactured by Olympus America, Inc. and is supplied as a single-use or reusable item. It received FDA 510(k) clearance with the number K950166 on February 22, 1995, and is regulated under product code KNS with regulation number 876.4300.

Other devices from Olympus America, Inc.

See all devices from Olympus America, Inc. →

Questions

AI-generated answers, 23 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 KD-6G1-9Q Wire Guided Papillotomu Knife used for?

    The Olympus KD-6G1-9Q Wire Guided Papillotomu Knife is an electrosurgical endoscopic unit designed for use in medical procedures, specifically classified as a Unit, Electrosurgical, Endoscopic device with or without accessories.

  • Is the Olympus KD-6G1-9Q Wire Guided Papillotomu Knife single-use or reusable?

    The Olympus KD-6G1-9Q Wire Guided Papillotomu Knife is supplied as either a single-use or reusable item, depending on the specific requirements of the medical procedure and healthcare facility protocols.

  • What regulatory approvals does the Olympus KD-6G1-9Q Wire Guided Papillotomu Knife have?

    The Olympus KD-6G1-9Q Wire Guided Papillotomu Knife received FDA 510(k) clearance with number K950166 on February 22, 1995, and is regulated under product code KNS with regulation number 876.4300.

  • Who manufactures the Olympus KD-6G1-9Q Wire Guided Papillotomu Knife?

    The Olympus KD-6G1-9Q Wire Guided Papillotomu Knife is manufactured by Olympus America, Inc., located at 4 Nevada Dr., Lake Success, NY 11042.