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510(k) K936026

COOK LAPAROSCOPIC MINI RETRACTOR SET by Cook Urological, Inc. — Product Code HFI

K936026 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "COOK LAPAROSCOPIC MINI RETRACTOR SET". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code HFI (Coagulator, Culdoscopic (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
December 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Culdoscopic (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
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 HFI

  • K151567 — ENDOPLUS hand-held laparoscopic instruments (December 23, 2015)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K930571 — REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING (February 1, 1994)
  • K844053 — CANON 60 DEGREE FUNDUS CAMERA CF-60S (December 19, 1984)

FDA data resources