510(k) K933148

SURGICAL DRAPE KIT by Nobelpharma USA, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 26, 1995
Date Received: June 29, 1993
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 Nobelpharma USA, Inc.

K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)
K962403 — NOBLEPHARMA WIDE ACCESSORIES (September 6, 1996)
K955713 — NOBELPHARMA BONE ANCHORED HEARING AID (August 9, 1996)
K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE (July 22, 1996)
K961736 — 17 ANGULATED ABUTMENT (July 18, 1996)
K961737 — CERA ONE ABUTMENT SYSTEM (July 10, 1996)
K961728 — MIRUSCONE ABUTMENT SYSTEM (July 10, 1996)
K960639 — ABUTMENT SELECTION KIT (May 14, 1996)
K955697 — ABUTMENT RETRIEVAL KIT (January 30, 1996)
K955372 — BALL ATTACHMENT SYSTEM (January 23, 1996)

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)