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, CAT # 11-003

K-Number: K983016 · 1999-02-12

ApplicantVitalcare Group, Inc.
Decision Date1999-02-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE, SPONGES, CAT # 11-003 is the device name listed in this FDA 510(k) record. The listed applicant is Vitalcare Group, Inc.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K983016. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE, SPONGES, CAT # 11-003?

GAUZE, SPONGES, CAT # 11-003 is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Vitalcare Group, Inc.. The 510(k) number is K983016.

When did GAUZE, SPONGES, CAT # 11-003 receive FDA 510(k) clearance?

GAUZE, SPONGES, CAT # 11-003 received FDA 510(k) clearance on 1999-02-12, under 510(k) number K983016.

Who is the listed applicant for GAUZE, SPONGES, CAT # 11-003?

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

What is the FDA product code for GAUZE, SPONGES, CAT # 11-003?

The FDA product code for GAUZE, SPONGES, CAT # 11-003 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 Vitalcare Group, 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.

K060109OMI RETRACTABLE SAFETY SYRINGEK050906VITALCARE I.V. ADMINISTRATION SETK040916VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVEK031748VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGESK992289VINYL POWDERED EXAM GLOVE / CAT.# 15-020K983716VITALCARE DISPOSABLE VAGINAL SPECULUM

View all 8 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.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.

↑