FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K Number: K021835
·
Decision Oct 17, 2002
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
17
Review Days
135
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Basic Information
- Device Name
- BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
- K Number
- K021835
- 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
- Brennen Medical, Inc.
- Date Received
- June 4, 2002
- Decision Date
- October 17, 2002
- 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 Brennen Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING | Feb 17, 2006 | Substantially Equivalent |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Mar 7, 2003 | Substantially Equivalent |
| K002078 | BETA GLUCAN GEL (MACROPRO GEL) | Oct 2, 2000 | Substantially Equivalent |
| K002077 | GLUCANPRO CREAM | Oct 2, 2000 | Substantially Equivalent |
| K000518 | MACROPRO GEL | May 1, 2000 | Substantially Equivalent |
| K000519 | GLUCANPRO | May 1, 2000 | Substantially Equivalent |
| K982825 | BRENNEN MEDICAL BETA GLUCAN GEL | Nov 6, 1998 | Substantially Equivalent |
| K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Sep 22, 1998 | Substantially Equivalent |
| K980962 | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO | Jul 29, 1998 | Substantially Equivalent |
| K964241 | BRENNEN MEDICAL GLUCAN II WOUND DRESSING | Dec 12, 1996 | Substantially Equivalent |