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FDA 510(k)

BIOTEQUE VAGINAL DILATOR

K-Number: K003380 · 2001-01-29

ApplicantBioteque America, Inc.
Decision Date2001-01-29
Product CodeHDX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIOTEQUE VAGINAL DILATOR 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 2001-01-29 under 510(k) number K003380. The device is classified under product code HDX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQUE VAGINAL DILATOR?

BIOTEQUE VAGINAL DILATOR is a medical device that received FDA 510(k) clearance on 2001-01-29. The listed applicant is Bioteque America, Inc.. The 510(k) number is K003380.

When did BIOTEQUE VAGINAL DILATOR receive FDA 510(k) clearance?

BIOTEQUE VAGINAL DILATOR received FDA 510(k) clearance on 2001-01-29, under 510(k) number K003380.

Who is the listed applicant for BIOTEQUE VAGINAL DILATOR?

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 BIOTEQUE VAGINAL DILATOR?

The FDA product code for BIOTEQUE VAGINAL DILATOR is HDX.

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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 PESSARIESK920633PESSARY FLEXIBLE SILICONE NICHOLSK920747PESSARY FLEXIBLE SILICONE DONUT RINGK933628CYTOLOGY BRUSH

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Related Devices (Code: HDX)

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.

K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK233689Hope&Her Vaginal DilatorsLujena, Inc.K222492Hope&Her Vaginal DilatorsLujena, Inc.K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK220035Milli Vaginal DilatorMaterna MedicalK211959Milli Vaginal DilatorMaterna Medical

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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