PGU — Spatial Imaging For Display Of Endoscope Position Class II
FDA product code PGU covers "Spatial Imaging For Display Of Endoscope Position", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PGU
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To detect and display the shape of an inserted endoscope.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K134026 | olympus medical systems | ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT | March 7, 2014 |