Cleared Traditional

KOH COLPOTOMIZER SYSTEM (K954311) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954311 · CooperSurgical, Inc. · Obstetrics & Gynecology device
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Nov 1996
Decision
431d
Days
Class 2
Risk

K954311 is an FDA 510(k) clearance for the KOH COLPOTOMIZER SYSTEM. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1640 - 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 CooperSurgical, Inc. devices

Submission Details

510(k) Number K954311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date November 19, 1996
Days to Decision 431 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 160d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEW Culdoscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1640
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 - HEW Culdoscope (and Accessories)

All 17
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K954311.
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
K243152 · Applied Medical Resources Corp. · Oct 2025
Advincula Delineator Uterine Manipulator
K201086 · CooperSurgical, Inc. · May 2020
Transvaginal Access Platform
K191294 · Applied Medical Resources Corp. · Sep 2019
Advincula Delineator Uterine Manipulator
K180429 · CooperSurgical, Inc. · Mar 2018
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc. · Feb 2004
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc. · Feb 2000