510(k) K922828

ULCER WOUND TRAY by Ulti-Med Intl., Inc. — Product Code KKX

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: September 28, 1992
Date Received: June 12, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drape, Surgical, Antimicrobial
Device Class: Class II
Regulation Number: 878.4370
Review Panel: HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by Ulti-Med Intl., Inc.

K103011 — ULTICARE SAFETY INSULIN SYRINGE (February 2, 2011)
K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
K920989 — SURGICAL INSTRUMENT KIT, DISPOSABLE (October 19, 1992)
K914244 — STERILE CUSTOM SURGICAL KITS (February 24, 1992)
K914431 — ABSORBENT FIBER (December 4, 1991)
K912693 — POST OPERATIVE SPONGE (October 4, 1991)
K912692 — CONFORMING BANDAGE (October 4, 1991)
K904896 — EYE PAD (December 5, 1990)
K901465 — ABSORBABLE GAUZE DRAPE (June 12, 1990)

Other clearances for product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
K200238 — ControlRad Sterile Cover (April 26, 2020)
K163556 — MediClear PreOp (September 14, 2017)
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
K140195 — SURGICAL DRAPE (September 10, 2014)
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)