510(k) K183171
- Device
- ScopeSeal Duodenoscope Protective Device
- Applicant
- GI Scientific LLC
- 510(k) number
- K183171
- Product code
- ODB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-08
- Date received
- 2018-11-16
- Regulation
- 876.1500
- Classification name
- Endoscopic Contamination Prevention Sheath
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Scott Miller
- Address
- 4601 N. Fairfax Dr., Suite 1200 Arlington VA US 22203 22203
FDA Registration Numbers#
- 3010707607
- 3004447686
- 2032677
- 2950776
- 3010202439
- 9610617
- 2011171
- 3006546082
- 2020550
- 2029275
- 3014342096
Source Documents#
Other 510(k) Records For Product Code ODB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016-04-19 |
| K080550 | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | Minos Medical | 2008-06-10 |
| K060475 | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 | Olympus Medical Systems Corporation | 2006-03-17 |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | Karl Storz Endoskop GmbH | 1994-09-14 |
Legacy Summary#
summary
FDA Review#
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