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FDA 510(k)

ORAL SPONGE

K-Number: K830675 · 1983-03-24

ApplicantUnisplint Corp.
Decision Date1983-03-24
Product CodeGEO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Unisplint Corp.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830675. The device is classified under product code GEO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL SPONGE?

ORAL SPONGE is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Unisplint Corp.. The 510(k) number is K830675.

When did ORAL SPONGE receive FDA 510(k) clearance?

ORAL SPONGE received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830675.

Who is the listed applicant for ORAL SPONGE?

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

What is the FDA product code for ORAL SPONGE?

The FDA product code for ORAL SPONGE is GEO.

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 Unisplint 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.

K820944DENTAL ARCH BAR

Related Devices (Code: GEO)

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.

K844145GENERAL SURGICAL FILESMed-Tool, 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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