FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K Number: K080022
·
Decision Dec 9, 2008
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
103
Review Days
341
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Basic Information
- Device Name
- GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
- K Number
- K080022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- January 3, 2008
- Decision Date
- December 9, 2008
- Product Code
- KHJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHJ), ordered by most recent decision date.
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
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FDA Class 2
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Biodesign Otologic Repair Graft
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FDA Class 2
·Ear, Nose, Throat
Biodesign Otologic Repair Graft
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·Ear, Nose, Throat
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BIODESIGN ENT REPAIR GRAFT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Vascular Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182232 | Octane Mechanical Thrombectomy System | Sep 11, 2018 | Substantially Equivalent |
| K181647 | Bandit guidewire | Jul 20, 2018 | Substantially Equivalent |
| K180913 | VSI Micro-Introducer Kit | May 9, 2018 | Substantially Equivalent |
| K180088 | TrapLiner catheter | Apr 4, 2018 | Substantially Equivalent |
| K180128 | Warrior 14 guidewire | Feb 16, 2018 | Substantially Equivalent |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | Jan 19, 2018 | Substantially Equivalent |
| K173532 | Raider Guidewire | Dec 15, 2017 | Substantially Equivalent |
| K173266 | Octane aspiration system | Dec 1, 2017 | Substantially Equivalent |
| K170544 | Langston dual lumen catheter | Nov 17, 2017 | Substantially Equivalent |
| K171946 | Gel-Bead | Oct 25, 2017 | Substantially Equivalent |