FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
K Number: K232372
·
Decision Jul 12, 2024
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
7
Review Days
339
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Basic Information
- Device Name
- Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
- K Number
- K232372
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peters Surgical
- Date Received
- August 8, 2023
- Decision Date
- July 12, 2024
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Peters Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K233265 | Monotime and Optime R | Oct 11, 2024 | Substantially Equivalent |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Aug 3, 2007 | Substantially Equivalent |
| K060465 | PREMIO | Jan 17, 2007 | Substantially Equivalent |
| K060163 | CARDIOFLON, CARDIOXYL | Oct 11, 2006 | Substantially Equivalent |
| K062366 | OPTIME, SINUSORB PGA | Oct 2, 2006 | Substantially Equivalent |
| K052701 | COROLENE | Dec 13, 2005 | Substantially Equivalent |