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FDA 510(k)

SEALOUETTE FIBRIN SEALANT APPLICATOR

K-Number: K992351 · 1999-10-08

ApplicantBiosurgical Corp.
Decision Date1999-10-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEALOUETTE FIBRIN SEALANT APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Biosurgical Corp.. It received FDA 510(k) clearance on 1999-10-08 under 510(k) number K992351. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALOUETTE FIBRIN SEALANT APPLICATOR?

SEALOUETTE FIBRIN SEALANT APPLICATOR is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Biosurgical Corp.. The 510(k) number is K992351.

When did SEALOUETTE FIBRIN SEALANT APPLICATOR receive FDA 510(k) clearance?

SEALOUETTE FIBRIN SEALANT APPLICATOR received FDA 510(k) clearance on 1999-10-08, under 510(k) number K992351.

Who is the listed applicant for SEALOUETTE FIBRIN SEALANT APPLICATOR?

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

What is the FDA product code for SEALOUETTE FIBRIN SEALANT APPLICATOR?

The FDA product code for SEALOUETTE FIBRIN SEALANT APPLICATOR is FMF.

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 Biosurgical Corp. 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.

K000438MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSERK000048SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1K964597BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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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