Cleared Traditional

K161065 - ColpoWave Colpotomizer and CerviGrip Ut...

K161065 is an FDA 510(k) clearance for ColpoWave Colpotomizer and CerviGrip Ut..., manufactured by Surgitools Pty , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEW cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K161065 · Surgitools Pty , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
195d
Days
Class 2
Risk

K161065 is an FDA 510(k) clearance for the ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by Surgitools Pty , Ltd. (Woodvale, AU). The FDA issued a Cleared decision on October 27, 2016 after a review of 195 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.

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FDA 510(k) Submission Details - K161065

510(k) Number K161065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2016
Decision Date October 27, 2016
Days to Decision 195 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
35d slower than avg
Panel avg: 160d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEW Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K161065.
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
GelPOINT Transvaginal Access Platform
K143308 · Applied Medical Resources · Oct 2015
CooperSurgical Advincula Delineator Uterine Manipulator
K143650 · CooperSurgical, Inc. · Jul 2015
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc. · Feb 2004