Cleared Traditional

K051160 - MANIPUSEAL

K051160 is an FDA 510(k) clearance for MANIPUSEAL, manufactured by Insitu Systems. The device is a Class 2 Obstetrics & Gynecology device with product code HEW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K051160 · Insitu Systems · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Sep 2005
Decision
120d
Days
Class 2
Risk

K051160 is an FDA 510(k) clearance for the MANIPUSEAL. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by Insitu Systems (North Attleboro, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 120 days - within the typical 510(k) review window.

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 Insitu Systems devices

FDA 510(k) Submission Details - K051160

510(k) Number K051160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2005
Decision Date September 02, 2005
Days to Decision 120 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
40d faster than avg
Panel avg: 160d · This submission: 120d
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 15
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K051160.
CooperSurgical Advincula Delineator Uterine Manipulator
K143650 · CooperSurgical, Inc. · Jul 2015
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
K111014 · Lsi Solutions, Inc. · Jul 2012
SINGHMED ROOLIP MANIPULATOR
K110819 · J.Singh Instruments · Oct 2011
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc. · Feb 2004
FERTILOSCOPY KIT FH 1.29/FTO 1.40
K992655 · Soprane S.A. · Mar 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc. · Feb 2000