Cleared Traditional

K993308 - MENTOR EVACARE VAGINAL PESSARIES (FDA 510(k) Clearance)

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

K993308 · Mentor Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
70d
Days
Class 2
Risk

K993308 is an FDA 510(k) clearance for the MENTOR EVACARE VAGINAL PESSARIES. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 13, 1999 after a review of 70 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 Mentor Corp. devices

Submission Details

510(k) Number K993308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date December 13, 1999
Days to Decision 70 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
90d faster than avg
Panel avg: 160d · This submission: 70d
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
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K993308.
Milex™ Incontinence Dish Pessaries
K253698 · Cooper Surgical · Jan 2026
CooperSurgical Milex® Pessaries
K250438 · CooperSurgical, Inc. · Apr 2025
Cntrl+ Bladder Support Pessary
K240798 · Cntrl+, Inc. · Dec 2024
Reia pessary
K232677 · Reia, LLC · May 2024
Yoni.Fit Bladder Support
K232525 · Watkins-Conti Products, Inc. · May 2024
Uresta®
K233548 · Resilia, Inc. · Apr 2024