MONOTEX
FDA 510(k) clearance K140415 · decided 2014-03-26
Clearance details
- K-number
- K140415
- Device name
- MONOTEX
- Applicant
- Riverpoint Medical
- Decision
- Substantially Equivalent
- Date received
- 2014-02-18
- Decision date
- 2014-03-26
- Days to decision
- 36 days
- Clearance type
- Abbreviated
- Product code
- NBY
- Device class
- 2
- Regulation number
- 878.5035
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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| C-PTFETM Surgical Suture (K173922) | Cp Medical, Inc. | 2018-03-26 |
| Gazelle PTFE and Suture Delivery Device (K173335) | Dura Tap, LLC | 2018-02-08 |
| WEGO-PTFE (K170842) | Foosin Medical Supplies Inc., Ltd. | 2017-07-31 |
| GOLNIT Non-Absorbable PTFE Surgical Suture (K163049) | Antarma Dba Golnit Sutures | 2017-06-21 |
| LS-5 ePTFE Suture (K163639) | Lsi Solutions | 2017-06-02 |
| LOOK PTFE Suture (K160744) | Surgical Specialties Corporation | 2016-07-13 |
Recalls involving this device
No recalls on record reference this clearance.