FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K Number: K122434
·
Decision Oct 31, 2012
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
14
Applicant Total
9
Review Days
82
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Basic Information
- Device Name
- MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
- K Number
- K122434
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Xomed
- Date Received
- August 10, 2012
- Decision Date
- October 31, 2012
- Product Code
- NHB
- 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 |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Medtronic Xomed
| K Number | Device Name | ||
|---|---|---|---|
| K202623 | Novapak Nasal Sinus Packing and Stent | Dec 8, 2020 | Substantially Equivalent |
| K031510 | NIM-SPINE | Jun 18, 2003 | Substantially Equivalent |
| K002972 | MEROGEL CONTROL GEL ENT SURGICAL DRESSING | Dec 15, 2000 | Substantially Equivalent |
| K002224 | XPS 3000 SYSTEM | Dec 4, 2000 | Substantially Equivalent |
| K000728 | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE | Mar 21, 2000 | Substantially Equivalent |
| K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR | Oct 22, 1999 | Substantially Equivalent |
| K963727 | HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER | Feb 11, 1997 | Substantially Equivalent |
| K963246 | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT | Sep 23, 1996 | Substantially Equivalent |