Mesh, Surgical, Deployment Balloon
The Mesh, Surgical, Deployment Balloon (product code OQL) is a device used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of hernias. It functions as a delivery mechanism rather than a permanent implant, assisting surgeons in deploying surgical mesh during minimally invasive procedures. As an FDA Class 2 device under regulation 878.3300, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device carries no implant or life-sustaining flags. It is not subject to third-party review.
Research product code OQL in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OQL
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
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 |
|---|---|---|---|---|
| K092726 | MESH GPS - LARGE, SMALL, SM, SM SMALL | Mar 15, 2010 | Substantially Equivalent | Surgical Structures , Ltd. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.