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FDA 510(k)

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM

K-Number: K052420 · 2006-04-06

ApplicantGynova, LLC
Decision Date2006-04-06
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Gynova, LLC. It received FDA 510(k) clearance on 2006-04-06 under 510(k) number K052420. 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 G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM?

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2006-04-06. The listed applicant is Gynova, LLC. The 510(k) number is K052420.

When did G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM receive FDA 510(k) clearance?

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM received FDA 510(k) clearance on 2006-04-06, under 510(k) number K052420.

Who is the listed applicant for G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM?

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

What is the FDA product code for G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM?

The FDA product code for G-SPEC ARTICULATED WEIGHTED 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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