Home / 510(k) Clearances / K950776

510(k) K950776

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

K950776 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "BIPOLAR SNARE". The FDA issued a decision of Substantially Equivalent on April 18, 1995. The device falls under product code GAE (Snare, Surgical), a Class I device regulated under 21 CFR 878.4800. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Cook Urological, Inc.

  • K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (May 6, 2011)
  • K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER (October 9, 2009)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (November 7, 2008)
  • K082536 — COOK WIRE GUIDES (October 27, 2008)
  • K082319 — INJEKT FILIFORM INJECTION NEEDLE (September 25, 2008)
  • K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (April 17, 2008)
  • K073496 — OPTILITE HOLMIUM LASER FIBERS (January 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (August 17, 2006)

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)

FDA data resources