Skip to content

Auto Suture Kerrison Spinal Rongeur

by United States Surgical, A Division of Tyco Healthc

510(k) K943116

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK943116 Date27 Jul 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2832-2011 FDA Unclassified (pre-2012) initiated 25 May 2011 on shared 510(k) K943116

    Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheobronchial strictures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HAE
Device Class
Class II
Regulation
21 CFR Part 882.4840
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Auto Suture Kerrison Spinal Rongeur is a manual rongeur device. It is designed for use in surgical procedures to cut or remove bone tissue.

This device is regulated under FDA product code HAE and is classified under neurology. It has received FDA 510(k) clearance.

Other devices from United States Surgical, A Division of Tyco Healthc

See all devices from United States Surgical, A Division of Tyco Healthc →