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GELITA-SPON® STANDARD

GELITA MEDICAL GmbH · Model GS-610 · UDI-DI 04260293133175

LYA KHJ Prescription

510(k) clearances

202

Adverse events (3 deaths)

Recalls

105

Facilities

Description

The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable. Its porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptive capacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes. It is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.

Recalls

Date	Firm	Reason
2022-07-27	GELITA MEDICAL GMBH	In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
2006-07-11	Porex Surgical, Inc.	Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.