OTK — Wound Drain Catheter System Class II
FDA product code OTK covers "Wound Drain Catheter System", a Class II medical device regulated under 21 CFR 878.4780. Submissions are reviewed by the General, Plastic Surgery panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OTK
- Device Class
- Class II
- Regulation Number
- 878.4780
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203394 | clearflow | PleuraFlow System with FlowGlide | March 2, 2021 |
| K191733 | clearflow | The ZIP Accessory Shuttle for PleuraFlow System | July 26, 2019 |
| K182067 | clearflow | PleuraFlow System with FlowGlide Extra Drainage Length | August 14, 2018 |
| K163139 | clearflow | PleuraFlow System with FlowGlide | November 30, 2016 |
| K153681 | clearflow | PleuraFlow System | January 20, 2016 |
| K150042 | clearflow | PleuraFlow System | June 2, 2015 |
| K093565 | clear catheter systems | PLEURAFLOW CATHETER SYSTEM | December 3, 2010 |