Cleared Traditional

PELVX GELLHORN VAGINAL PESSARY 603-608 (K002329) - FDA 510(k) Clearance

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

K002329 · Deschutes Medical Products, Inc. · Obstetrics & Gynecology device
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Sep 2000
Decision
48d
Days
Class 2
Risk

K002329 is an FDA 510(k) clearance for the PELVX GELLHORN VAGINAL PESSARY 603-608. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Deschutes Medical Products, Inc. (Bend, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deschutes Medical Products, Inc. devices

Submission Details

510(k) Number K002329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date September 18, 2000
Days to Decision 48 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
112d faster than avg
Panel avg: 160d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 - HHW Pessary, Vaginal

All 40
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