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FDA 510(k)

GELITA-SPON ABSORBABLE GELATIN SPONGE, USP

K-Number: K060878 · 2006-04-13

ApplicantCuramedical, BV
Decision Date2006-04-13
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GELITA-SPON ABSORBABLE GELATIN SPONGE, USP is the device name listed in this FDA 510(k) record. The listed applicant is Curamedical, BV. It received FDA 510(k) clearance on 2006-04-13 under 510(k) number K060878. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELITA-SPON ABSORBABLE GELATIN SPONGE, USP?

GELITA-SPON ABSORBABLE GELATIN SPONGE, USP is a medical device that received FDA 510(k) clearance on 2006-04-13. The listed applicant is Curamedical, BV. The 510(k) number is K060878.

When did GELITA-SPON ABSORBABLE GELATIN SPONGE, USP receive FDA 510(k) clearance?

GELITA-SPON ABSORBABLE GELATIN SPONGE, USP received FDA 510(k) clearance on 2006-04-13, under 510(k) number K060878.

Who is the listed applicant for GELITA-SPON ABSORBABLE GELATIN SPONGE, USP?

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

What is the FDA product code for GELITA-SPON ABSORBABLE GELATIN SPONGE, USP?

The FDA product code for GELITA-SPON ABSORBABLE GELATIN SPONGE, USP is KHJ.

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.

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Other records listing Curamedical, BV 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.

K051911GELITA-SPON

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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