510(k) K911520

ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE by Andronic Devices, Ltd. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 2, 1991
Date Received: April 4, 1991
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 Andronic Devices, Ltd.

K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
K934928 — INSITE FILTER & TUBING SET (May 26, 1994)
K934926 — INSITE MODEL 20 & MODEL 15 INSUFFLATORS (May 26, 1994)
K935381 — KAPS POSITIONING ARM (April 15, 1994)
K934124 — AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM (April 13, 1994)
K936308 — ENDEX ENDOSCOPIC POSITIONING SYSTEM (March 31, 1994)
K932253 — ARTHROBOT BI-FOLD DRAPE (February 3, 1994)
K922625 — ADEPT ENDOSCOPIC POSITIONER (October 19, 1992)
K922626 — ADEPT INSTRUMENT POSITIONING ACCESSORY (October 19, 1992)
K911521 — ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP (August 2, 1991)

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)