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)

GENERAL USE SYNTHETIC SPONGE (STERILE)

K-Number: K955527 · 1996-02-05

ApplicantIgenics, Inc.
Decision Date1996-02-05
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GENERAL USE SYNTHETIC SPONGE (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Igenics, Inc.. It received FDA 510(k) clearance on 1996-02-05 under 510(k) number K955527. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL USE SYNTHETIC SPONGE (STERILE)?

GENERAL USE SYNTHETIC SPONGE (STERILE) is a medical device that received FDA 510(k) clearance on 1996-02-05. The listed applicant is Igenics, Inc.. The 510(k) number is K955527.

When did GENERAL USE SYNTHETIC SPONGE (STERILE) receive FDA 510(k) clearance?

GENERAL USE SYNTHETIC SPONGE (STERILE) received FDA 510(k) clearance on 1996-02-05, under 510(k) number K955527.

Who is the listed applicant for GENERAL USE SYNTHETIC SPONGE (STERILE)?

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

What is the FDA product code for GENERAL USE SYNTHETIC SPONGE (STERILE)?

The FDA product code for GENERAL USE SYNTHETIC 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 Igenics, 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.

K963134DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)K955165SYNTHETIC SPONGE

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.

↑