Cleared Traditional

K920187 - FLEXIBLE SILICONE GELIHORN

K920187 is an FDA 510(k) clearance for FLEXIBLE SILICONE GELIHORN, manufactured by Bioteque America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K920187 · Bioteque America, Inc. · Obstetrics & Gynecology device
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Oct 1992
Decision
283d
Days
Class 2
Risk

K920187 is an FDA 510(k) clearance for the FLEXIBLE SILICONE GELIHORN. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Bioteque America, Inc. (Levittown, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 283 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.

View all Bioteque America, Inc. devices

FDA 510(k) Submission Details - K920187

510(k) Number K920187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1992
Decision Date October 23, 1992
Days to Decision 283 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 160d · This submission: 283d
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 21
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K920187.
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
K965040 · Johnson & Johnson Medical, Inc. · Mar 1997
VAGINAL CONTINENCE DEVICE
K930618 · Johnson & Johnson Medical, Inc. · May 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654 · Johnson & Johnson Medical, Inc. · May 1995
FEMALE CONTINENCE DEVICE
K883721 · Cook Ob/Gyn · Oct 1988
SILASTIC BRAND INTRAVAGINAL TARSETTE
K771548 · Dow Corning Corp. Healthcare Industries Materials · Nov 1977