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510(k) K914883

CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG by Circon Video — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
October 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Circon Video

  • K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE (April 9, 2002)
  • K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (January 8, 2002)
  • K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETER (December 10, 2001)
  • K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (November 19, 2001)
  • K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (November 9, 2001)
  • K012925 — DUR-8, MODELS DUR-8 (November 7, 2001)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K011848 — CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (September 11, 2001)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)

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