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Med-Surg Suture Washer

by Medical Surgical, Inc.

510(k) K950250

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)SN Traditional NumberK950250 Date17 May 1995DecidedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 24 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 Med-Surg Suture Washer is a device used in surgical settings to clean sutures during procedures. It is designed to facilitate the removal of debris and contaminants from suture material prior to use.

This device is supplied as a reusable instrument and was cleared via the FDA 510(k) process under K950250. It is classified under product code HWC and was determined to be substantially equivalent for some indications, with authorization granted on May 17, 1995.

Questions

AI-generated answers, 24 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 Med-Surg Suture Washer used for?

    The Med-Surg Suture Washer is used in surgical settings to clean sutures by facilitating the removal of debris and contaminants from suture material prior to use, helping ensure the suture is clean before implantation or tying.

  • Is the Med-Surg Suture Washer reusable or single-use?

    The Med-Surg Suture Washer is supplied as a reusable instrument, meaning it is designed to be cleaned, sterilized, and used multiple times across different procedures in accordance with the manufacturer’s reprocessing instructions.

  • How was the Med-Surg Suture Washer cleared for use in the United States?

    The Med-Surg Suture Washer was cleared via the FDA 510(k) process under submission K950250, with a determination of substantial equivalence for some indications, and authorization was granted on May 17, 1995.