Gel-Sponge ENT, Absorbable Gelatin Sponge, Usp
FDA 510(k) K080022 · Vascular Solutions, Inc.
510(k) numberK080022
Submission
- Device name
- Gel-Sponge ENT, Absorbable Gelatin Sponge, Usp
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- January 3, 2008
- Decision date
- December 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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Questions and answers
When was Gel-Sponge ENT, Absorbable Gelatin Sponge, Usp cleared by the FDA?
Gel-Sponge ENT, Absorbable Gelatin Sponge, Usp (K080022) received a 510(k) decision of Substantially Equivalent on December 9, 2008, 341 days after the submission was received.
What is the product code of K080022?
The FDA product code is KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), a Class II (moderate risk) device regulated under 21 CFR 874.3620.