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510(k) K936308

ENDEX ENDOSCOPIC POSITIONING SYSTEM by Andronic Devices, Ltd. — Product Code FQO

K936308 is an FDA 510(k) premarket notification submitted by Andronic Devices, Ltd. for the device "ENDEX ENDOSCOPIC POSITIONING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 1994. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Andronic Devices, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

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)
  • 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)
  • K911520 — ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE (August 2, 1991)

Other clearances for product code FQO

  • K240598 — Maestro System (REF100) (June 3, 2024)
  • K221410 — Maestro Platform (December 2, 2022)
  • K090136 — STERIS CMAX XLT SURGICAL TABLE (March 20, 2009)
  • K972810 — OPT80 THE TRANSPORTABLE (OPT80) (August 26, 1997)
  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K971307 — AMSCO SURGICAL TABLE (June 27, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K955750 — TELETOM (February 8, 1996)

FDA data resources