FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUOROTEX SURGICAL MESH
K Number: K984197
·
Decision Jan 7, 1999
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
7
Review Days
45
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Basic Information
- Device Name
- FLUOROTEX SURGICAL MESH
- K Number
- K984197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bridger Biomed, Inc.
- Date Received
- November 23, 1998
- Decision Date
- January 7, 1999
- Product Code
- FTL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Bridger Biomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003906 | MODIFICATION TO FLUROTEX SURGICAL MESH | Jan 26, 2001 | Substantially Equivalent |
| K003917 | MODIFICATION TO FLUOROTEX II SURGICAL MESH | Jan 26, 2001 | Substantially Equivalent |
| K002351 | FLUOROTEX II SURGICAL MESH | Aug 26, 2000 | Substantially Equivalent |
| K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | Jul 7, 2000 | Substantially Equivalent |
| K980548 | DURA-PATCH MODEL DP-XXX | May 13, 1998 | Substantially Equivalent |
| K973178 | FLUORO-TEX SURGICAL MEMBRANE | Nov 24, 1997 | Substantially Equivalent |