GELITA-SPON ABSORBABLE GELATIN SPONGE, USP— 510(k) K060878

Name: FDA 510(k) clearance K060878
Creator: U.S. Food and Drug Administration
Published: 2006-04-13

Substantially Equivalent

Curamedical, BV

FDA 510(k) clearance K060878 for GELITA-SPON ABSORBABLE GELATIN SPONGE, USP, Substantially Equivalent on 2006-04-13. Applicant: Curamedical, BV. Device class: 2.

Clearance details

Applicant: Curamedical, BV
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2006-03-31
Decision date: 2006-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Claremont, NH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060878

K-number listed on FDA's recall record

Z-1768-2022 — ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAMClass II·Completed·GELITA MEDICAL GMBH·20220727

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060878.

Data sourced from openFDA. This site is unofficial and independent of the FDA.