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510(k) K061651

FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 by Apple Medical Corp. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2006
Date Received
June 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

Other clearances by Apple Medical Corp.

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  • K014005 — APPLE MEDICAL MOBIUS ELASTIC RETRACTOR (February 15, 2002)
  • K000026 — APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER (March 31, 2000)
  • K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE (March 27, 1997)
  • K961460 — LWEET CONE BIOPSY INSTRUMENT (November 19, 1996)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 1994)

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  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)