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FDA 510(k)

IVALON EXTERNAL SPONGE

K-Number: K946015 · 1995-02-27

ApplicantIvalon
Decision Date1995-02-27
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IVALON EXTERNAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Ivalon. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K946015. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVALON EXTERNAL SPONGE?

IVALON EXTERNAL SPONGE is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Ivalon. The 510(k) number is K946015.

When did IVALON EXTERNAL SPONGE receive FDA 510(k) clearance?

IVALON EXTERNAL SPONGE received FDA 510(k) clearance on 1995-02-27, under 510(k) number K946015.

Who is the listed applicant for IVALON EXTERNAL SPONGE?

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

What is the FDA product code for IVALON EXTERNAL SPONGE?

The FDA product code for IVALON EXTERNAL SPONGE is NAB.

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 Ivalon 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.

K946016IVALON OPHTHALMIC SPONGEK913556IVALON EMBOLIZATION PARTICLES

Related Devices (Code: NAB)

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.

K940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, Inc.K924650GAUZE SPONGESDav-Mar Medical Products, 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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