Cleared Traditional

K031463 - MARINA MEDICAL SILICONE PESSARY

K031463 is an FDA 510(k) clearance for MARINA MEDICAL SILICONE PESSARY, manufactured by Marina Medical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K031463 · Marina Medical Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
194d
Days
Class 2
Risk

K031463 is an FDA 510(k) clearance for the MARINA MEDICAL SILICONE PESSARY. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Marina Medical Instruments, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 18, 2003 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031463

510(k) Number K031463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2003
Decision Date November 18, 2003
Days to Decision 194 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
33d slower than avg
Panel avg: 161d · This submission: 194d
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 39
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K031463.
URESTA PESSARY
K081385 · Eastmed, Inc. · Oct 2008
TIPI
K060526 · Contipi , Ltd. · Jun 2006
KOLPEXIN SPHERE
K032644 · Adamed , Ltd. · May 2004
MTI ST#1 SILICONE PESSARY
K020512 · Medical Technology and Innovations, Inc. · May 2002
PORTEX RING PESSARY PVC-NON STERILE
K012277 · Sims Portex , Ltd. · Feb 2002
BIOTEQUE VAGINAL PESSARIES
K013289 · Bioteque America, Inc. · Dec 2001
K031463 · MARINA MEDICAL SILICONE PESSARY
Download PDF FDA Summary Marina Medical Instru…