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FDA 510(k)

SILIMED VAGINAL STENT

K-Number: K974479 · 1998-08-05

ApplicantSilimed, LLC
Decision Date1998-08-05
Product CodeKXP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SILIMED VAGINAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Silimed, LLC. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K974479. The device is classified under product code KXP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILIMED VAGINAL STENT?

SILIMED VAGINAL STENT is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Silimed, LLC. The 510(k) number is K974479.

When did SILIMED VAGINAL STENT receive FDA 510(k) clearance?

SILIMED VAGINAL STENT received FDA 510(k) clearance on 1998-08-05, under 510(k) number K974479.

Who is the listed applicant for SILIMED VAGINAL STENT?

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

What is the FDA product code for SILIMED VAGINAL STENT?

The FDA product code for SILIMED VAGINAL STENT is KXP.

Related Clinical Trials

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Other records listing Silimed, LLC 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.

K981852SILIMED TISSUE EXPANDERK981835SILIMED MALAR IMPLANTK981850SILIMED CHIN IMPLANTSK981851SILIMED SILICONE CARVING BLOCKK981833SILIMED NASAL L SHAPED IMPLANTK980221SILIMED NASAL RETAINER

View all 9 devices →

Related Devices (Code: KXP)

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.

K202542Allura Vaginal StentPmt CorporationK983045AMIELLEOwen Mumford USA, Inc.K920633PESSARY FLEXIBLE SILICONE NICHOLSBioteque America, 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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