Cleared Traditional

K143650 - CooperSurgical Advincula Delineator Ute...

K143650 is the FDA 510(k) clearance for CooperSurgical Advincula Delineator Ute... by CooperSurgical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEW) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K143650 · CooperSurgical, Inc. · Obstetrics & Gynecology device
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Jul 2015
Decision
210d
Days
Class 2
Risk

K143650 is an FDA 510(k) clearance for the CooperSurgical Advincula Delineator Uterine Manipulator. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on July 21, 2015 after a review of 210 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperSurgical, Inc. devices

Submission Details

510(k) Number K143650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2014
Decision Date July 21, 2015
Days to Decision 210 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
50d slower than avg
Panel avg: 160d · This submission: 210d
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 Consultant

Orchid Design
Tim M Lohnes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEW Culdoscope (and Accessories)

All 9
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K143650.
Transvaginal Access Platform
K191294 · Applied Medical Resources Corp. · Sep 2019
Advincula Delineator Uterine Manipulator
K180429 · CooperSurgical, Inc. · Mar 2018
GelPOINT Transvaginal Access Platform
K143308 · Applied Medical Resources · Oct 2015
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc. · Feb 2004
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc. · Feb 2000
ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
K964276 · Richard Wolf Medical Instruments Corp. · Nov 1997