Cleared Traditional

K940265 - PATTON LAPAROSCOPIC CATHETER INTRODUCER...

K940265 is the FDA 510(k) clearance for PATTON LAPAROSCOPIC CATHETER INTRODUCER... by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 615-day FDA review.

K940265 · Cook Urological, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 1995
Decision
615d
Days
Class 2
Risk

K940265 is an FDA 510(k) clearance for the PATTON LAPAROSCOPIC CATHETER INTRODUCER SET. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on September 28, 1995 after a review of 615 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K940265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date September 28, 1995
Days to Decision 615 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
455d slower than avg
Panel avg: 160d · This submission: 615d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 131
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K940265.
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · Olympus America, Inc. · Oct 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
KSEA MODEL 203200 20 UNIMAT
K953190 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · Olympus America, Inc. · Sep 1995
KARL STORZ SUCTION CATHETERS
K951250 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
STRYKER OPERATING LAPAROSCOPE
K943100 · Stryker Endoscopy · Aug 1995