Cleared Special

K083769 - MODIFICATION TO URESTA PESSARY

K083769 is an FDA 510(k) clearance for MODIFICATION TO URESTA PESSARY, manufactured by Eastmed, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Special 510(k) pathway after a 27-day FDA review.

K083769 · Eastmed, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K083769

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 161d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 38
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K083769.
PANPAC INFLATABLE DOCUT PESSARY
K132670 · Panpac Medical Corporation · Jun 2014
TIPI OTC
K131198 · Contipi , Ltd. · Aug 2013
PANPAC VAGINAL PESSARY
K092981 · Panpac Medical Corporation · Jul 2010
URESTA PESSARY
K081385 · Eastmed, Inc. · Oct 2008
TIPI
K060526 · Contipi , Ltd. · Jun 2006
KOLPEXIN SPHERE
K032644 · Adamed , Ltd. · May 2004
K083769 · MODIFICATION TO URESTA PESSARY
Download PDF FDA Summary Eastmed, Inc.