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FDA 510(k)

IVALON OPHTHALMIC SPONGE

K-Number: K946016 · 1995-03-22

ApplicantIvalon
Decision Date1995-03-22
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IVALON OPHTHALMIC SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Ivalon. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K946016. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVALON OPHTHALMIC SPONGE?

IVALON OPHTHALMIC SPONGE is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Ivalon. The 510(k) number is K946016.

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

IVALON OPHTHALMIC SPONGE received FDA 510(k) clearance on 1995-03-22, under 510(k) number K946016.

Who is the listed applicant for IVALON OPHTHALMIC 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 OPHTHALMIC SPONGE?

The FDA product code for IVALON OPHTHALMIC SPONGE is HOZ.

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.

K946015IVALON EXTERNAL SPONGEK913556IVALON EMBOLIZATION PARTICLES

Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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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