Cleared Traditional

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633

K974647 · Customed, Inc. · General Hospital
Jan 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K974647 is an FDA 510(k) clearance for the FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on January 5, 1998, 24 days after receiving the submission on December 12, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K974647 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1997
Decision Date January 05, 1998
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

Similar Devices — KKX Drape, Surgical

All 449
BeneHold? Surgical Incise Drape with CHG antimicrobial II
K230645 · Avery Dennison Medical , Ltd. · Oct 2023
3M? Ioban? CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · 3M Company · May 2023
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
MediClear PreOp
K163556 · Covalontechnologies, Inc. · Sep 2017
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
K133080 · Foshan Nanhai Plus Medical Co, Ltd. · Jun 2015