Pessary Flexible Silicone Nichols

FDA 510(k) K920633 · Bioteque America, Inc.

Substantially Equivalent

510(k) numberK920633

Submission

Device name
Pessary Flexible Silicone Nichols
Applicant
Bioteque America, Inc.
Langhorne, PA, US
Received
February 12, 1992
Decision date
November 8, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KXP – Stent, Vaginal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.3900
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code KXP

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K202542Allura Vaginal StentKXP · Traditional Pmt Corporation09/30/2020SE
K983045AmielleKXP · Traditional Owen Mumford USA, Inc.11/25/1998SE
K974479Silimed Vaginal StentKXP · Traditional Silimed, LLC08/05/1998SE

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K013289Bioteque Vaginal PessariesHHW · Traditional 12/27/2001SE
K003380Bioteque Vaginal DilatorHDX · Traditional 01/29/2001SE
K920747Pessary Flexible Silicone Donut RingHHW · Traditional 08/29/1994SE
K933628Cytology BrushHHT · Traditional 03/11/1994SE
K933521SpeculumHIB · Traditional 03/07/1994SE
K920187Flexible Silicone GelihornHHW · Traditional 10/23/1992SE
K920177Versa-VialDQF · Traditional 07/13/1992SE

Questions and answers

When was Pessary Flexible Silicone Nichols cleared by the FDA?

Pessary Flexible Silicone Nichols (K920633) received a 510(k) decision of Substantially Equivalent on November 8, 1995, 1,365 days after the submission was received.

What is the product code of K920633?

The FDA product code is KXP – Stent, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.