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)

CYLINDRICAL SPONGE

K-Number: K945866 · 1994-12-28

ApplicantLorrex Health Products
Decision Date1994-12-28
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYLINDRICAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Lorrex Health Products. It received FDA 510(k) clearance on 1994-12-28 under 510(k) number K945866. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYLINDRICAL SPONGE?

CYLINDRICAL SPONGE is a medical device that received FDA 510(k) clearance on 1994-12-28. The listed applicant is Lorrex Health Products. The 510(k) number is K945866.

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

CYLINDRICAL SPONGE received FDA 510(k) clearance on 1994-12-28, under 510(k) number K945866.

Who is the listed applicant for CYLINDRICAL SPONGE?

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

What is the FDA product code for CYLINDRICAL SPONGE?

The FDA product code for CYLINDRICAL SPONGE is GDY.

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 Lorrex Health Products 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.

K945335CHERRY DISSECTORK945553ROUND STICK SPONGES, FLAT STICK SPONGESK945606TRIANGULAR SPONGESK945333KITTNER DISSECTORK945334CHERRY PIT DISSECTORK945336PEANUT DISSECTOR

View all 16 devices →

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical Perspectives Corp.

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.

↑