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FDA 510(k)

PESSARY FLEXIBLE SILICONE NICHOLS

K-Number: K920633 · 1995-11-08

ApplicantBioteque America, Inc.
Decision Date1995-11-08
Product CodeKXP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PESSARY FLEXIBLE SILICONE NICHOLS is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque America, Inc.. It received FDA 510(k) clearance on 1995-11-08 under 510(k) number K920633. The device is classified under product code KXP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PESSARY FLEXIBLE SILICONE NICHOLS?

PESSARY FLEXIBLE SILICONE NICHOLS is a medical device that received FDA 510(k) clearance on 1995-11-08. The listed applicant is Bioteque America, Inc.. The 510(k) number is K920633.

When did PESSARY FLEXIBLE SILICONE NICHOLS receive FDA 510(k) clearance?

PESSARY FLEXIBLE SILICONE NICHOLS received FDA 510(k) clearance on 1995-11-08, under 510(k) number K920633.

Who is the listed applicant for PESSARY FLEXIBLE SILICONE NICHOLS?

The FDA 510(k) record lists Bioteque America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PESSARY FLEXIBLE SILICONE NICHOLS?

The FDA product code for PESSARY FLEXIBLE SILICONE NICHOLS is KXP.

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Other records listing Bioteque America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041094HSG CATHETER SETK020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5K013289BIOTEQUE VAGINAL PESSARIESK003380BIOTEQUE VAGINAL DILATORK920747PESSARY FLEXIBLE SILICONE DONUT RINGK933628CYTOLOGY BRUSH

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Related Devices (Code: KXP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202542Allura Vaginal StentPmt CorporationK983045AMIELLEOwen Mumford USA, Inc.K974479SILIMED VAGINAL STENTSilimed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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