FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
K Number: K190777
·
Decision Jul 31, 2019
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
5
Review Days
127
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Basic Information
- Device Name
- DemeTECH DemeFORCE Nonabsorbable Surgical Suture
- K Number
- K190777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Demetech Corporation
- Date Received
- March 26, 2019
- Decision Date
- July 31, 2019
- 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 Demetech Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K201479 | DemeMASK | Jul 24, 2020 | Substantially Equivalent |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Nov 7, 2019 | Substantially Equivalent |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Oct 11, 2018 | Substantially Equivalent |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Aug 27, 2018 | Substantially Equivalent |