FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
EXPANDED BODY SUTURE
K Number: K961025
·
Decision Apr 15, 1996
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
8
Review Days
32
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Basic Information
- Device Name
- EXPANDED BODY SUTURE
- K Number
- K961025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Medicinelodge, Inc.
- Date Received
- March 14, 1996
- Decision Date
- April 15, 1996
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medicinelodge, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072525 | ZIPKNOT, MODEL 1017-3000 | Oct 5, 2007 | Substantially Equivalent |
| K051488 | MEDICINELODGE ZIPKNOT | Jul 27, 2005 | Substantially Equivalent |
| K962705 | MLI MODULAR STAPLE | Oct 1, 1996 | Substantially Equivalent |
| K961920 | CROSS PIN | Sep 17, 1996 | Substantially Equivalent |
| K961905 | MEDICINELODGE, INC. SET SCREW | Aug 6, 1996 | Substantially Equivalent |
| K962194 | MLI SOFT TISSUE SCREW & WASHER SYSTEM | Jul 30, 1996 | Substantially Equivalent |
| K953350 | MLI INTERFERENCE SCREW | Jan 30, 1996 | Substantially Equivalent for Some Indications |