DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX— 510(k) K042526

Name: FDA 510(k) clearance K042526
Creator: U.S. Food and Drug Administration
Published: 2005-04-25

Substantially Equivalent

Medical Action Industries, Inc.

FDA 510(k) clearance K042526 for DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX, Substantially Equivalent on 2005-04-25. Applicant: Medical Action Industries, Inc.. Device class: 2.

Clearance details

Applicant: Medical Action Industries, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2004-09-17
Decision date: 2005-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden, 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 Medical Action Industries, Inc.

view all

K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-91072004-11-08
K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L2002-11-04
K946019 — SURGICLA INSTRUMENT KIT1995-03-20
K923846 — BURN DRESSING1992-09-11
K884826 — GAUZE SPONGE1988-12-22

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