POLY-LINED TOWEL/DRAPE LINE— 510(k) K850199

Name: FDA 510(k) clearance K850199
Creator: U.S. Food and Drug Administration
Published: 1985-02-21

Substantially Equivalent

Excel Health Care Products

FDA 510(k) clearance K850199 for POLY-LINED TOWEL/DRAPE LINE, Substantially Equivalent on 1985-02-21. Applicant: Excel Health Care Products. Device class: 2.

Clearance details

Applicant: Excel Health Care Products
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1985-01-18
Decision date: 1985-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Plainfield, NJ, 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 Excel Health Care Products

view all

K850960 — NON-ABSORBENT DRAPES & ABSORBENT TOWELS1986-03-15
K850456 — TRACHEOSTOMY CARE KIT1985-03-11
K850325 — STERILE SUTURE REMOVAL KIT1985-02-26
K850326 — STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH1985-02-26

Recalls naming K850199

K-number listed on FDA's recall record

Z-1240-2020 — Arrow Maximal Barrier Drape ASK-00002-1AClass II·Terminated·Arrow International Inc·20191220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K850199.

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