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FDA 510(k)

SPECULUM

K-Number: K933521 · 1994-03-07

ApplicantBioteque America, Inc.
Decision Date1994-03-07
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECULUM 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 1994-03-07 under 510(k) number K933521. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECULUM?

SPECULUM is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Bioteque America, Inc.. The 510(k) number is K933521.

When did SPECULUM receive FDA 510(k) clearance?

SPECULUM received FDA 510(k) clearance on 1994-03-07, under 510(k) number K933521.

Who is the listed applicant for SPECULUM?

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 SPECULUM?

The FDA product code for SPECULUM is HIB.

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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 DILATORK920633PESSARY FLEXIBLE SILICONE NICHOLSK920747PESSARY FLEXIBLE SILICONE DONUT RING

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Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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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