Wound Drain Catheter System
The Wound Drain Catheter System (product code OTK) is a surgical drainage device used as an adjunct during open surgical procedures to prevent fluid accumulation within the operative site after wound closure. It is specifically indicated for use in thoracic surgical procedures. As an FDA Class 2 device under regulation 878.4780, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OTK
- Device Class
- FDA class 2
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | Mar 02, 2021 | Substantially Equivalent | Clearflow, Inc. |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Jul 26, 2019 | Substantially Equivalent | Clearflow, Inc. |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Aug 14, 2018 | Substantially Equivalent | Clearflow, Inc. |
| K163139 | PleuraFlow System with FlowGlide | Nov 30, 2016 | Substantially Equivalent | Clearflow, Inc. |
| K153681 | PleuraFlow System | Jan 20, 2016 | Substantially Equivalent | Clearflow, Inc. |
| K150042 | PleuraFlow System | Jun 02, 2015 | Substantially Equivalent | Clearflow, Inc. |
| K093565 | PLEURAFLOW CATHETER SYSTEM | Dec 03, 2010 | Substantially Equivalent | Clear Catheter Systems |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.