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)

STICK SPONGE

K-Number: K882712 · 1988-08-03

ApplicantBioseal
Decision Date1988-08-03
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

STICK SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Bioseal. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K882712. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STICK SPONGE?

STICK SPONGE is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Bioseal. The 510(k) number is K882712.

When did STICK SPONGE receive FDA 510(k) clearance?

STICK SPONGE received FDA 510(k) clearance on 1988-08-03, under 510(k) number K882712.

Who is the listed applicant for STICK SPONGE?

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

What is the FDA product code for STICK SPONGE?

The FDA product code for STICK SPONGE 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 Bioseal 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.

K893814SURGICAL INSTRUMENT KIT, DISPOSABLEK882695RUBBER BAND, STERILEK882696DERMICEL, MONTGOMERY STRAPK882694FIXATION DEVICE, TRACH TUBEK882711GAUZE SPONGE 12PLYK882708GAUZE SPONGE, X-RAY DETECTABLE

View all 10 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.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.

↑