FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEROGEL OTOLOGIC PACK
K Number: K001148
·
Decision Jun 3, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
82
Review Days
54
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Basic Information
- Device Name
- MEROGEL OTOLOGIC PACK
- K Number
- K001148
- 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
- Xomed, Inc.
- Date Received
- April 10, 2000
- Decision Date
- June 3, 2000
- 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)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biodesign Otologic Repair Graft
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biodesign Otologic Repair Graft
FDA 510(k)
FDA Class 2
·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 Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Dec 11, 2000 | Substantially Equivalent |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Dec 4, 2000 | Substantially Equivalent |
| K002828 | XPS NITRO SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Oct 11, 2000 | Substantially Equivalent |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Jun 9, 2000 | Substantially Equivalent |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |
| K993112 | XOMED ENT RF SYSTEM | Dec 9, 1999 | Substantially Equivalent |