StitchKit
FDA 510(k) clearance K191317 · decided 2019-07-12
Clearance details
- K-number
- K191317
- Device name
- StitchKit
- Applicant
- Origami Surgical
- Decision
- Substantially Equivalent
- Date received
- 2019-05-15
- Decision date
- 2019-07-12
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- NBY
- Device class
- 2
- Regulation number
- 878.5035
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Madison, NJ, 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 |
|---|---|---|
| TissueStat (K231277) | Durastat, LLC | 2023-11-09 |
| GOLNIT Non-aborbable PTFE Surgical Suture (K192088) | Antarma, LLC Dba Golnit Sutures | 2019-09-04 |
| Biotex (K180992) | Purgo Biologics, Inc. | 2019-07-16 |
| DemeTECH PTFE Nonabsorbable Surgical Suture (K181578) | Demetech Corporation | 2018-10-11 |
| PTFE SURGICAL SUTURE (K180630) | Omnia Spa | 2018-04-06 |
| 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 |
| MONOTEX (K140415) | Riverpoint Medical | 2014-03-26 |
Recalls involving this device
No recalls on record reference this clearance.