DISPOSABLE O.R. TOWEL— 510(k) K912110

Name: FDA 510(k) clearance K912110
Creator: U.S. Food and Drug Administration
Published: 1991-07-25

Substantially Equivalent

American Threshold Industries, Inc.

FDA 510(k) clearance K912110 for DISPOSABLE O.R. TOWEL, Substantially Equivalent on 1991-07-25. Applicant: American Threshold Industries, Inc.. Device class: 2.

Clearance details

Applicant: American Threshold Industries, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1991-05-13
Decision date: 1991-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enka, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

view all

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from American Threshold Industries, Inc.

view all

K971483 — SECURE-WRAP (TM) STERILIZATION WRAP1997-06-24
K953878 — BOUFFANT CAP1996-01-05
K953879 — SURGEON'S CAP1996-01-05
K952114 — KOOL GARD SINGLES GOWN1995-09-25
K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN1995-09-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.