510(k) K970185

STERILE DISPOSABLE EQUIPMENT MAGNET COVER by Contour Fabricators, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 10, 1997
Date Received: January 17, 1997
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 Contour Fabricators, Inc.

K090773 — CFI ULTRASOUND PROBE DRAPE (September 18, 2009)
K970900 — INSTRUMENT HOLDER (May 22, 1997)
K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER (January 30, 1997)
K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (November 15, 1996)
K820692 — BANDBAG, WRAP, STERILE (May 3, 1982)
K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

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)