The following data is part of a premarket notification filed by Gi Scientific Llc with the FDA for Scopeseal Duodenoscope Protective Device.
| Device ID | K183171 |
| 510k Number | K183171 |
| Device Name: | ScopeSeal Duodenoscope Protective Device |
| Classification | Endoscopic Contamination Prevention Sheath |
| Applicant | GI Scientific LLC 4601 North Fairfax Drive, Suite 1200 Arlington, VA 22203 |
| Contact | Scott Miller |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255 |
| Product Code | ODB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-10-08 |
| Summary: | summary |