OXT — Percutaneous Surgical Set With Attachments Class II
FDA product code OXT covers "Percutaneous Surgical Set With Attachments", a Class II medical device regulated under 21 CFR 878.4805. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OXT
- Device Class
- Class II
- Regulation Number
- 878.4805
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN110016 | ethicon endo-surgery | PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS | April 30, 2012 |