Cleared Traditional

K993308 - MENTOR EVACARE VAGINAL PESSARIES

K993308 is an FDA 510(k) clearance for MENTOR EVACARE VAGINAL PESSARIES, manufactured by Mentor Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

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

FDA 510(k) Submission Details - K993308

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
Combination Product No
PCCP Authorized No
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.

HHW Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K993308.
TIPI OTC
K131198 · Contipi , Ltd. · Aug 2013
URESTA PESSARY
K081385 · Eastmed, Inc. · Oct 2008
TIPI
K060526 · Contipi , Ltd. · Jun 2006
PELVX INCONTINENCE DISH, MODEL 301-306
K990593 · Deschutes Medical Products, Inc. · May 1999
PELVX RING, PELVX RING WITH SUPPORT
K974115 · Deschutes Medical Products, Inc. · Apr 1998
PELVX INCONTINENCE RING
K974116 · Deschutes Medical Products, Inc. · Apr 1998