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FDA 510(k)

CLEARSPEC SINGLE USE VAGINAL SPECULUM

K-Number: K130046 · 2013-08-06

ApplicantClearspec, LLC
Decision Date2013-08-06
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CLEARSPEC SINGLE USE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Clearspec, LLC. It received FDA 510(k) clearance on 2013-08-06 under 510(k) number K130046. 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 CLEARSPEC SINGLE USE VAGINAL SPECULUM?

CLEARSPEC SINGLE USE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2013-08-06. The listed applicant is Clearspec, LLC. The 510(k) number is K130046.

When did CLEARSPEC SINGLE USE VAGINAL SPECULUM receive FDA 510(k) clearance?

CLEARSPEC SINGLE USE VAGINAL SPECULUM received FDA 510(k) clearance on 2013-08-06, under 510(k) number K130046.

Who is the listed applicant for CLEARSPEC SINGLE USE VAGINAL SPECULUM?

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

What is the FDA product code for CLEARSPEC SINGLE USE VAGINAL SPECULUM?

The FDA product code for CLEARSPEC SINGLE USE 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, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp CorporationK072942MEDLINE DISPOSABLE VAGINAL SPECULUMMedline Industries, Inc.

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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