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FDA 510(k)

POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM

K-Number: K040817 · 2004-06-22

ApplicantAdvanced Urological Developments
Decision Date2004-06-22
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Urological Developments. It received FDA 510(k) clearance on 2004-06-22 under 510(k) number K040817. 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 POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM?

POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2004-06-22. The listed applicant is Advanced Urological Developments. The 510(k) number is K040817.

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

POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM received FDA 510(k) clearance on 2004-06-22, under 510(k) number K040817.

Who is the listed applicant for POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM?

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

What is the FDA product code for POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM?

The FDA product code for POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM is HIB.

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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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