BIOFIBER SYTURE
FDA 510(k) clearance K122487 · decided 2012-09-17
Clearance details
- K-number
- K122487
- Device name
- BIOFIBER SYTURE
- Applicant
- Tornier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-15
- Decision date
- 2012-09-17
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- NWJ
- Device class
- 2
- Regulation number
- 878.4494
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bloomington, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GalaSTITCH Absorbable Monofilament Suture (K211307) | Tepha, Inc. | 2021-05-27 |
| TEPHAFLEX BRAIDED SUTURE (K132348) | Tepha, Inc. | 2013-09-05 |
| PHANTOM FIBER BIOFIBER SUTURE (K130422) | Tornier, Inc. | 2013-04-04 |
| AESCULAP MONOMAX ABSORBABLE SUTURE (K100876) | Aesculap, Inc. | 2010-07-14 |
| TEPHAFLEX ABSORBABLE SUTURE (K082178) | Tepha, Inc. | 2008-10-30 |
| TEPHAFLEX ABSORBABLE SUTURE (K081099) | Tepha, Inc. | 2008-07-15 |
| BIOELAST 5-0 SUTURE, MODEL 500100 (K072470) | Entrigue Surgical, Inc. | 2007-11-16 |
| TEPHAFLEX ABSORBABLE SUTURE (DEN060003) | Tepha, Inc. | 2007-02-08 |
Recalls involving this device
No recalls on record reference this clearance.