FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOPYLEN
K Number: K922630
·
Decision Oct 20, 1992
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
16
Review Days
139
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Basic Information
- Device Name
- MOPYLEN
- K Number
- K922630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S. Jackson, Inc.
- Date Received
- June 3, 1992
- Decision Date
- October 20, 1992
- Product Code
- GAW
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by S. Jackson, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080216 | SUPRAMESH EXTRA | Sep 15, 2008 | Substantially Equivalent |
| K973379 | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS | Sep 25, 1997 | Substantially Equivalent |
| K931614 | MOPYLEN SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K931613 | SUPRAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K931612 | NYLAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K912429 | N80-838 SUPRAMID EXTRA SUTURE | Oct 2, 1991 | Substantially Equivalent |
| K904052 | SUPRAMID EXTRA SUTURES | Oct 25, 1990 | Substantially Equivalent |
| K852011 | NYLAMID MESH PAD FULL & HALF | Jun 11, 1985 | Substantially Equivalent |
| K831725 | FOIL IN 3 FORMS-NON-STERILE SHEETS | Aug 16, 1983 | Substantially Equivalent |
| K831727 | QUARTER GLOBE CAPS | Aug 12, 1983 | Substantially Equivalent |