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Master & Frank Surgical Drapes (Sterile)

by Master & Frank Enterprses Co., Ltd.

510(k) K020393

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK020393 Date3 May 2002ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1889-2026 FDA Class II initiated 27 Feb 2026

    Unapproved design changes to the products outside of the 510(k) clearance.

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  • Withdrawn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