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FDA 510(k)

HAYES VAGINAL SHIELD

K-Number: K862478 · 1986-11-24

ApplicantFranklin Medical USA, Inc.
Decision Date1986-11-24
Product CodeHDF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HAYES VAGINAL SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Franklin Medical USA, Inc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K862478. The device is classified under product code HDF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAYES VAGINAL SHIELD?

HAYES VAGINAL SHIELD is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Franklin Medical USA, Inc.. The 510(k) number is K862478.

When did HAYES VAGINAL SHIELD receive FDA 510(k) clearance?

HAYES VAGINAL SHIELD received FDA 510(k) clearance on 1986-11-24, under 510(k) number K862478.

Who is the listed applicant for HAYES VAGINAL SHIELD?

The FDA 510(k) record lists Franklin Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAYES VAGINAL SHIELD?

The FDA product code for HAYES VAGINAL SHIELD is HDF.

Related Clinical Trials

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Other records listing Franklin Medical USA, Inc. as applicant

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.

K931488KSF SPINAL FIXATORK884589FRANTZ MEDICAL SHARPS COLLECTORK852200SIMPLASTIC SUPRA PUBIC CATHETER

Related Devices (Code: HDF)

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.

K926429VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTThomasville Medical Assoc.K902019MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPSGynescope Corp.K891041MIYA SPECULUMZinnanti Surgical Instruments, Inc.K891044LASER SPECULAZinnanti Surgical Instruments, Inc.K890375VAGINAL SPECULUMKinetic Medical ProductsK853640WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINALDowns Surgical , Ltd.

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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