Home / 510(k) Clearances / K911521

510(k) K911521

ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP by Andronic Devices, Ltd. — Product Code KKX

K911521 is an FDA 510(k) premarket notification submitted by Andronic Devices, Ltd. for the device "ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Andronic Devices, Ltd. has at least 10 other 510(k) clearances on record.

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)
  • K922626 — ADEPT INSTRUMENT POSITIONING ACCESSORY (October 19, 1992)
  • K922625 — ADEPT ENDOSCOPIC POSITIONER (October 19, 1992)
  • K911520 — ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE (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)

FDA data resources