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FDA 510(k)

DURASIL

K-Number: K952612 · 1995-11-22

ApplicantThe S. F. Group, Inc.
Decision Date1995-11-22
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURASIL is the device name listed in this FDA 510(k) record. The listed applicant is The S. F. Group, Inc.. It received FDA 510(k) clearance on 1995-11-22 under 510(k) number K952612. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURASIL?

DURASIL is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is The S. F. Group, Inc.. The 510(k) number is K952612.

When did DURASIL receive FDA 510(k) clearance?

DURASIL received FDA 510(k) clearance on 1995-11-22, under 510(k) number K952612.

Who is the listed applicant for DURASIL?

The FDA 510(k) record lists The S. F. Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURASIL?

The FDA product code for DURASIL is MDA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The S. F. Group, 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.

K961410DURASIL (MODIFICATION)

Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, Inc.

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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