LumenR Tissue Retractor System
FDA 510(k) clearance K153698 · decided 2016-04-19
Clearance details
- K-number
- K153698
- Device name
- LumenR Tissue Retractor System
- Applicant
- Lumenr, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-12-23
- Decision date
- 2016-04-19
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- ODB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Matawan, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ScopeSeal Duodenoscope Protective Device (K183171) | Gi Scientific, LLC | 2019-10-08 |
| MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 (K080550) | Minos Medical | 2008-06-10 |
| EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 (K060475) | Olympus Medical Systems Corporation | 2006-03-17 |
| TROCARS,CANNULAE,SHEATHS,OBTURATORS (K943697) | Karl Storz Endoskop GmbH | 1994-09-14 |
Recalls involving this device
No recalls on record reference this clearance.