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FDA 510(k)

VAGATEX

K-Number: K782083 · 1979-01-03

ApplicantVagatex
Decision Date1979-01-03
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAGATEX is the device name listed in this FDA 510(k) record. The listed applicant is Vagatex. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K782083. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGATEX?

VAGATEX is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Vagatex. The 510(k) number is K782083.

When did VAGATEX receive FDA 510(k) clearance?

VAGATEX received FDA 510(k) clearance on 1979-01-03, under 510(k) number K782083.

Who is the listed applicant for VAGATEX?

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

What is the FDA product code for VAGATEX?

The FDA product code for VAGATEX is HIR.

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Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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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