Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPONGE COUNT

K-Number: K945144 · 1995-01-12

ApplicantMichael Fischer Assoc.
Decision Date1995-01-12
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPONGE COUNT is the device name listed in this FDA 510(k) record. The listed applicant is Michael Fischer Assoc.. It received FDA 510(k) clearance on 1995-01-12 under 510(k) number K945144. The device is classified under product code LWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPONGE COUNT?

SPONGE COUNT is a medical device that received FDA 510(k) clearance on 1995-01-12. The listed applicant is Michael Fischer Assoc.. The 510(k) number is K945144.

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

SPONGE COUNT received FDA 510(k) clearance on 1995-01-12, under 510(k) number K945144.

Who is the listed applicant for SPONGE COUNT?

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

What is the FDA product code for SPONGE COUNT?

The FDA product code for SPONGE COUNT is LWH.

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

Related Devices (Code: LWH)

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.

K121274PIXEL APPGauss Surgical, Inc.,K120473PIXEL APPGauss Surgical, Inc.,K100551ORLOCATE SYSTEM MODEL ORL 100Haldor Advanced Technologies, Ltd.K093557SMARTWAND-DTXClearcount Medical SolutionsK073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, 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.

↑