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FDA 510(k)

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP

K-Number: K080022 · 2008-12-09

ApplicantVascular Solutions, Inc.
Decision Date2008-12-09
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2008-12-09 under 510(k) number K080022. 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 GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP?

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K080022.

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

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP received FDA 510(k) clearance on 2008-12-09, under 510(k) number K080022.

Who is the listed applicant for GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP?

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

What is the FDA product code for GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP?

The FDA product code for GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP is KHJ.

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Other records listing Vascular Solutions, Inc. as applicant

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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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