Cleared Traditional

K960262 - CORING MORCELLATOR

K960262 is the FDA 510(k) clearance for CORING MORCELLATOR by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K960262 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
88d
Days
Class 2
Risk

K960262 is an FDA 510(k) clearance for the CORING MORCELLATOR. 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 April 15, 1996 after a review of 88 days - a notably fast clearance cycle.

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

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K960262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1996
Decision Date April 15, 1996
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 K960262.
A4907 LENS CLEANING SHEATH
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RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
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KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · KARL STORZ Endoscopy-America, Inc. · May 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc. · Apr 1996
OES LAPARO-THORACO VIDEOSCOPE TYPE V
K955403 · Olympus America, Inc. · Mar 1996
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
K955456 · Olympus America, Inc. · Feb 1996