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)

STERILE AND NON-STERILE GAUZE SPONGES

K-Number: K922055 · 1992-08-10

ApplicantTeam Mfg., Inc.
Decision Date1992-08-10
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

STERILE AND NON-STERILE GAUZE SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Team Mfg., Inc.. It received FDA 510(k) clearance on 1992-08-10 under 510(k) number K922055. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE AND NON-STERILE GAUZE SPONGES?

STERILE AND NON-STERILE GAUZE SPONGES is a medical device that received FDA 510(k) clearance on 1992-08-10. The listed applicant is Team Mfg., Inc.. The 510(k) number is K922055.

When did STERILE AND NON-STERILE GAUZE SPONGES receive FDA 510(k) clearance?

STERILE AND NON-STERILE GAUZE SPONGES received FDA 510(k) clearance on 1992-08-10, under 510(k) number K922055.

Who is the listed applicant for STERILE AND NON-STERILE GAUZE SPONGES?

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

What is the FDA product code for STERILE AND NON-STERILE GAUZE SPONGES?

The FDA product code for STERILE AND NON-STERILE GAUZE SPONGES 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 Team Mfg., Inc. 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.

K922054STERILE GAUZE SPONGES X-RAY DETECTABLEK904934AUTOMASTER

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.

↑