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)

GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

K-Number: K990584 · 1999-04-23

ApplicantBroadline Medical Industries
Decision Date1999-04-23
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Broadline Medical Industries. It received FDA 510(k) clearance on 1999-04-23 under 510(k) number K990584. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE?

GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1999-04-23. The listed applicant is Broadline Medical Industries. The 510(k) number is K990584.

When did GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE receive FDA 510(k) clearance?

GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE received FDA 510(k) clearance on 1999-04-23, under 510(k) number K990584.

Who is the listed applicant for GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE?

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

What is the FDA product code for GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE?

The FDA product code for GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE 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 Broadline Medical Industries 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.

K991667BROADLINE OR TOWELS

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.K984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.K983348DYNAREX TRACHEOSTOMY SPONGEDynarex 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.

↑