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Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/Dexter Wrap

by Avail-Southwest Division

510(k) K950830

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 NumberK950830 Date3 May 1995ClearedStatusActive

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  • Withdrawn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
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The device is a non-magnetic instrument drape used in surgical settings to cover and protect instruments during procedures. It is designed to prevent magnetic interference and maintain a sterile field.

It is supplied in sizes including 16x20, 16x10, and includes a Dexter wrap variant. The device is intended for single-use, provided sterile, and is regulated under FDA 510(k) clearance K950830 with product code KKX, classified as a drape under regulation 878.4370 for general and plastic surgery applications.

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