MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
FDA 510(k) clearance K053636 · decided 2006-03-14
Clearance details
- K-number
- K053636
- Device name
- MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
- Applicant
- Mani, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-29
- Decision date
- 2006-03-14
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, pack recall (Z-0649-2012) | Mani, Inc. - Kiyohara Facility | 2012-01-11 |
| MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, pack recall (Z-0650-2012) | Mani, Inc. - Kiyohara Facility | 2012-01-11 |
| MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, pack recall (Z-0651-2012) | Mani, Inc. - Kiyohara Facility | 2012-01-11 |
| MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, pack recall (Z-0652-2012) | Mani, Inc. - Kiyohara Facility | 2012-01-11 |
| MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, pack recall (Z-0653-2012) | Mani, Inc. - Kiyohara Facility | 2012-01-11 |
| MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, pack recall (Z-0654-2012) | Mani, Inc. - Kiyohara Facility | 2012-01-11 |