GLOBAL SHOULDER O.R. DRAPE PACK— 510(k) K941233

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K941233 for GLOBAL SHOULDER O.R. DRAPE PACK, Substantially Equivalent on 1994-07-27. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-03-15
Decision date: 1994-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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 Depuy, Inc.

K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS2005-03-14
K042664 — LPS UPPER EXTREMITY2004-12-08
K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY2004-07-22
K033959 — LPS2004-07-01
K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -0622004-05-28

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