510(k) K813360

DERMAFILE (CAT. # 38 by Exco, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 18, 1982
Date Received: November 30, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drape, Surgical, Antimicrobial
Device Class: Class II
Regulation Number: 878.4370
Review Panel: HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by Exco, Inc.

K844203 — ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 (January 2, 1985)
K844175 — ENTERNAL FEEDING TUBE-POLYURETHANE EF504 (January 2, 1985)
K844174 — FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI (December 7, 1984)
K832628 — VYGON THORACIC DRAINAGE-VARIOUS #'S (January 30, 1984)
K831802 — LIFE VAC #2191 & 2192 (January 11, 1984)
K833079 — CENTRACATH #130,135 & 137-HEMOCATH # (December 29, 1983)
K830910 — MANOMETER SET C.V.P. #S 298/299 (April 5, 1983)
K822879 — ENTERAL NUTRITION 1 (November 16, 1982)
K822691 — VYGON EPIDURAL ANAESTHESIA TRAY (October 15, 1982)
K822836 — MICROFLEX-VENOFLUX (October 15, 1982)

Other clearances for product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
K200238 — ControlRad Sterile Cover (April 26, 2020)
K163556 — MediClear PreOp (September 14, 2017)
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
K140195 — SURGICAL DRAPE (September 10, 2014)
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)