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)

USP TYPE VII GAUZE SPONGES

K-Number: K923378 · 1992-10-06

ApplicantE.W.A., Ltd.
Decision Date1992-10-06
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

USP TYPE VII GAUZE SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is E.W.A., Ltd.. It received FDA 510(k) clearance on 1992-10-06 under 510(k) number K923378. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USP TYPE VII GAUZE SPONGES?

USP TYPE VII GAUZE SPONGES is a medical device that received FDA 510(k) clearance on 1992-10-06. The listed applicant is E.W.A., Ltd.. The 510(k) number is K923378.

When did USP TYPE VII GAUZE SPONGES receive FDA 510(k) clearance?

USP TYPE VII GAUZE SPONGES received FDA 510(k) clearance on 1992-10-06, under 510(k) number K923378.

Who is the listed applicant for USP TYPE VII GAUZE SPONGES?

The FDA 510(k) record lists E.W.A., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for USP TYPE VII GAUZE SPONGES?

The FDA product code for USP TYPE VII GAUZE SPONGES is NAB.

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 E.W.A., Ltd. 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.

K943339GAUZE SPONGE (E.W.A. LTD./VARIOUS)

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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.

↑