Cleared Traditional

SINGHMED ROOLIP MANIPULATOR (K110819) - FDA 510(k) Clearance

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

K110819 · J.Singh Instruments · Obstetrics & Gynecology device
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Oct 2011
Decision
196d
Days
Class 2
Risk

K110819 is an FDA 510(k) clearance for the SINGHMED ROOLIP MANIPULATOR. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by J.Singh Instruments (Austin, US). The FDA issued a Cleared decision on October 5, 2011 after a review of 196 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 J.Singh Instruments devices

Submission Details

510(k) Number K110819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2011
Decision Date October 05, 2011
Days to Decision 196 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
36d slower than avg
Panel avg: 160d · This submission: 196d
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 K110819.
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
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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