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FDA 510(k)

GAUZE SPONGE STERILE

K-Number: K832173 · 1983-08-12

ApplicantSudreca Surgical Dressings, Inc.
Decision Date1983-08-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Sudreca Surgical Dressings, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832173. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE STERILE?

GAUZE SPONGE STERILE is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Sudreca Surgical Dressings, Inc.. The 510(k) number is K832173.

When did GAUZE SPONGE STERILE receive FDA 510(k) clearance?

GAUZE SPONGE STERILE received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832173.

Who is the listed applicant for GAUZE SPONGE STERILE?

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

What is the FDA product code for GAUZE SPONGE STERILE?

The FDA product code for GAUZE SPONGE STERILE 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 Sudreca Surgical Dressings, 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.

K832172GAUZE SPONGE X-RAY DETECTABLE-K832174GAUZE SPONGE NON-STERILEK831952SURGICAL APPAREL SHOE COVERS

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.

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