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Hand Pack (K914934)

by Westmark Hospital Supplies

510(k) K914934

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK914934 Date21 Jan 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Hand Pack
510(k) Number
FDA Product Code
KDO
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

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 Hand Pack is a Cystoscopic, Hot, Rongeur (Product Code KDO), designed for surgical use in gastroenterology and urology procedures. This device is intended for cutting, trimming, or removing tissue or foreign material during endoscopic or minimally invasive surgeries, where precise control and heat application are required.

Supplied as a single-use item, the Hand Pack is intended for use in sterile surgical settings. It is classified as a Class II medical device under FDA regulation 876.1500 and was cleared via a Traditional 510(k) pathway (K914934) in 1993. No additional sterility or MRI safety information is specified in the regulatory data.

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