510(k) K791032

CARDIAC CATHETERIZATION SHEETS/PACKS by Surgikos, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 15, 1979
Date Received: June 4, 1979
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 Surgikos, Inc.

K875107 — HEALTH CARE EYE PROTECTION (March 21, 1988)
K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
K861441 — NEUTRALON SURGICAL GLOVES (May 30, 1986)
K852870 — BARRIER SURGICAL GOWN (July 23, 1985)
K822535 — CIDEX*DIALYZER DISINFECTING SOLUTION (September 30, 1982)
K820543 — BARRIER ANTIMICROBIAL INCISE DRAPE (July 22, 1982)
K820542 — SURGIKOS INCISE DRAPE (June 2, 1982)
K811871 — BACTERICIDAL INCISE DRAPE (August 20, 1981)
K810316 — SURGIKOS FACE MASK (February 23, 1981)
K801864 — BARRIER APERTURED DRAPE (August 20, 1980)

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)