Cleared Special

MODIFICATION TO URESTA PESSARY (K083769) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083769 · Eastmed, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
27d
Days
Class 2
Risk

K083769 is an FDA 510(k) clearance for the MODIFICATION TO URESTA PESSARY. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Eastmed, Inc. (Dundas, CA). The FDA issued a Cleared decision on January 14, 2009 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eastmed, Inc. devices

Submission Details

510(k) Number K083769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2008
Decision Date January 14, 2009
Days to Decision 27 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 160d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K083769.
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