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FDA 510(k)

GELITA-SPON

K-Number: K051911 · 2005-12-06

ApplicantCuramedical, BV
Decision Date2005-12-06
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GELITA-SPON is the device name listed in this FDA 510(k) record. The listed applicant is Curamedical, BV. It received FDA 510(k) clearance on 2005-12-06 under 510(k) number K051911. 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?

GELITA-SPON is a medical device that received FDA 510(k) clearance on 2005-12-06. The listed applicant is Curamedical, BV. The 510(k) number is K051911.

When did GELITA-SPON receive FDA 510(k) clearance?

GELITA-SPON received FDA 510(k) clearance on 2005-12-06, under 510(k) number K051911.

Who is the listed applicant for GELITA-SPON?

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?

The FDA product code for GELITA-SPON 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.

K060878GELITA-SPON ABSORBABLE GELATIN SPONGE, USP

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

View on FDA Database →

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

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