Percutaneous Surgical Set With Attachments
The Percutaneous Surgical Set with Attachments is a general surgery device consisting of minimally invasive instruments designed to penetrate soft tissue to access the abdomen, with attachments that can be assembled and disassembled within the abdomen for grasping, holding, and manipulating soft tissues. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXT, with regulation number 878.4805 under the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- OXT
- Device Class
- FDA class 2
- Regulation Number
- 878.4805
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN110016 | PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS | Apr 30, 2012 | Unknown | Ethicon Endo-Surgery |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.