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FDA 510(k)

HIERSPEC SPECULUM

K-Number: K061339 · 2006-09-19

ApplicantMedical Products Div.
Decision Date2006-09-19
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HIERSPEC SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products Div.. It received FDA 510(k) clearance on 2006-09-19 under 510(k) number K061339. 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 HIERSPEC SPECULUM?

HIERSPEC SPECULUM is a medical device that received FDA 510(k) clearance on 2006-09-19. The listed applicant is Medical Products Div.. The 510(k) number is K061339.

When did HIERSPEC SPECULUM receive FDA 510(k) clearance?

HIERSPEC SPECULUM received FDA 510(k) clearance on 2006-09-19, under 510(k) number K061339.

Who is the listed applicant for HIERSPEC SPECULUM?

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

What is the FDA product code for HIERSPEC SPECULUM?

The FDA product code for HIERSPEC 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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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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