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510(k) K950776

BIPOLAR SNARE by Cook Urological, Inc. — Product Code GAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1995
Date Received
February 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
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Other clearances for product code GAE

  • K926036 — ACUFEX SUTURE RETRIEVER (May 5, 1993)
  • K903174 — ADVANCE SUTURE ABSORBABLE GUT SUTURE (July 10, 1991)
  • K881224 — ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE (June 1, 1988)