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)

SURGEX SURGICAL SPONGE

K-Number: K761034 · 1977-01-05

ApplicantConvertors
Decision Date1977-01-05
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SURGEX SURGICAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Convertors. It received FDA 510(k) clearance on 1977-01-05 under 510(k) number K761034. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGEX SURGICAL SPONGE?

SURGEX SURGICAL SPONGE is a medical device that received FDA 510(k) clearance on 1977-01-05. The listed applicant is Convertors. The 510(k) number is K761034.

When did SURGEX SURGICAL SPONGE receive FDA 510(k) clearance?

SURGEX SURGICAL SPONGE received FDA 510(k) clearance on 1977-01-05, under 510(k) number K761034.

Who is the listed applicant for SURGEX SURGICAL SPONGE?

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

What is the FDA product code for SURGEX SURGICAL SPONGE?

The FDA product code for SURGEX SURGICAL SPONGE is EFQ.

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 Convertors 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.

K780627SURG-O-PAK, GOWNS, SHEETS, AND TOWELSK790234DRAPE PACKS, SURGICAL GOWNSK781959SURGICAL GOWNS, SHEETSK781534SURG-O-PAK PREP PADK781099SURGICAL GOWNS AND DRAPESK780169MASK, SURGICAL

View all 10 devices →

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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.

↑