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FDA 510(k)

INSTANT COLDGEL

K-Number: K953541 · 1995-10-05

ApplicantPrism Technologies, Inc.
Decision Date1995-10-05
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INSTANT COLDGEL is the device name listed in this FDA 510(k) record. The listed applicant is Prism Technologies, Inc.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K953541. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTANT COLDGEL?

INSTANT COLDGEL is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Prism Technologies, Inc.. The 510(k) number is K953541.

When did INSTANT COLDGEL receive FDA 510(k) clearance?

INSTANT COLDGEL received FDA 510(k) clearance on 1995-10-05, under 510(k) number K953541.

Who is the listed applicant for INSTANT COLDGEL?

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

What is the FDA product code for INSTANT COLDGEL?

The FDA product code for INSTANT COLDGEL is IMD.

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 Prism Technologies, 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.

K980212MITYVACK953542COLDGELK934631TRANSWARMERK912715INSTANT WARM GEL PACK

Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, 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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