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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 Mar 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 103 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 11, 1994
Date Received
Dec 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
510(k)

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 (Oct 9, 2009)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (Sep 3, 2009)
  • K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (Nov 7, 2008)
  • K082536 — COOK WIRE GUIDES (Oct 27, 2008)
  • K082319 — INJEKT FILIFORM INJECTION NEEDLE (Sep 25, 2008)
  • K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (Apr 17, 2008)
  • K073496 — OPTILITE HOLMIUM LASER FIBERS (Jan 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (Nov 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (Aug 17, 2006)

Other clearances for product code HFI

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

FDA data resources

Source: FDA 510(k) database entry for K936026. Report a data issue: hello@regdatalab.com.