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FDA 510(k)

FEMSPEC DISPOSABLE VAGINAL SPECULUM

K-Number: K041757 · 2004-12-23

ApplicantFemspec LLC
Decision Date2004-12-23
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMSPEC DISPOSABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Femspec LLC. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K041757. 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 FEMSPEC DISPOSABLE VAGINAL SPECULUM?

FEMSPEC DISPOSABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Femspec LLC. The 510(k) number is K041757.

When did FEMSPEC DISPOSABLE VAGINAL SPECULUM receive FDA 510(k) clearance?

FEMSPEC DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance on 2004-12-23, under 510(k) number K041757.

Who is the listed applicant for FEMSPEC DISPOSABLE VAGINAL SPECULUM?

The FDA 510(k) record lists Femspec LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMSPEC DISPOSABLE VAGINAL SPECULUM?

The FDA product code for FEMSPEC DISPOSABLE VAGINAL SPECULUM is HIB.

Related Clinical Trials

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.

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Other records listing Femspec LLC 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.

K060320FEMECC ENDOCERVICAL CURETTEK052192FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-IK051294FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1

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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