ScopeSeal Duodenoscope Protective Device
FDA 510(k) clearance K183171 · decided 2019-10-08
Clearance details
- K-number
- K183171
- Device name
- ScopeSeal Duodenoscope Protective Device
- Applicant
- Gi Scientific, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-11-16
- Decision date
- 2019-10-08
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- ODB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Arlington, VA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gi Scientific
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LumenR Tissue Retractor System (K153698) | Lumenr, LLC | 2016-04-19 |
| 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.