Cleared Traditional

ProVate Vaginal Support (K190277) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K190277 · Contipi Medical , Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
150d
Days
Class 2
Risk

K190277 is an FDA 510(k) clearance for the ProVate Vaginal Support. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Contipi Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 8, 2019 after a review of 150 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - 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 Contipi Medical , Ltd. devices

Submission Details

510(k) Number K190277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date July 08, 2019
Days to Decision 150 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
10d faster than avg
Panel avg: 160d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US Lpp
Jonathan S. Kahan

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.

Clinical Evidence

ClinicalTrials.gov
NCT02239133 Unknown Interventional Industry-sponsored

R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary

Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women

44
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pelvic Organ Prolapse
Study design Single group
Eligibility Female only · 21 Years+
Sponsor ConTIPI Medical (industry)
Started 2014-08-01 → Primary completion 2016-09-01
Primary outcome
Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination)
View full study on ClinicalTrials.gov

Regulatory Peers - HHW Pessary, Vaginal

All 40
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