Cleared Traditional

K936026 - COOK LAPAROSCOPIC MINI RETRACTOR SET

K936026 is an FDA 510(k) clearance for COOK LAPAROSCOPIC MINI RETRACTOR SET, manufactured by Cook Urological, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K936026 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
84d
Days
Class 2
Risk

K936026 is an FDA 510(k) clearance for the COOK LAPAROSCOPIC MINI RETRACTOR SET. Classified as Coagulator, Culdoscopic (and Accessories) (product code HFI), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K936026

510(k) Number K936026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1993
Decision Date March 11, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 161d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFI Device Classification - Class 2, Special Controls

Product Code HFI Coagulator, Culdoscopic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFI Coagulator, Culdoscopic (and Accessories)

All 7
Devices cleared under the same product code (HFI) and FDA review panel - the closest regulatory comparables to K936026.
ENDOPLUS hand-held laparoscopic instruments
K151567 · Endoplus · Dec 2015
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925957 · Zinnanti Surgical Instruments, Inc. · Jun 1994
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925960 · Zinnanti Surgical Instruments, Inc. · Jun 1994
DIAMOND-SHARP(R) TROCARS
K924148 · Snowden-Pencer · Feb 1994
LAPAROSCOPIC INSTRUMENTS
K925114 · Endo Technic Corp. · Feb 1994
REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
K930571 · Numed Technologies, Inc. · Feb 1994
K936026 · COOK LAPAROSCOPIC MINI RETRACTOR SET
Download PDF FDA Summary Cook Urological, Inc.