AM TM SYRGICAL DRAPES— 510(k) K882643

Name: FDA 510(k) clearance K882643
Creator: U.S. Food and Drug Administration
Published: 1989-03-03

Substantially Equivalent for Some Indications

Henley Intl.

FDA 510(k) clearance K882643 for AM TM SYRGICAL DRAPES, Substantially Equivalent for Some Indications on 1989-03-03. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant: Henley Intl.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1988-06-27
Decision date: 1989-03-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Sugar Land, TX, 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 Henley Intl.

view all

K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES1995-11-15
K926278 — STAIR CLIMBER1994-05-05
K926279 — UPPER BODY EXERCISER1994-05-05
K926287 — EXERCISE BICYCLE1994-03-22
K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER1994-03-18

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