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510(k) K934926

INSITE MODEL 20 & MODEL 15 INSUFFLATORS by Andronic Devices, Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
October 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by Andronic Devices, Ltd.

  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K934928 — INSITE FILTER & TUBING SET (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)
  • K911521 — ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP (August 2, 1991)

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