The following data is part of a premarket notification filed by Dex Surgical with the FDA for Dex Device.
| Device ID | K191878 |
| 510k Number | K191878 |
| Device Name: | DEX Device |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Dex Surgical 3 Rue Des Petits Ruisseaux Verrieres Le Buisson, FR 91370 |
| Contact | Guillaume Noury |
| Correspondent | Guillaume Noury Dex Surgical 3 Rue Des Petits Ruisseaux Verrieres Le Buisson, FR 91370 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665772000091 | K191878 | 000 |
| 03665772000015 | K191878 | 000 |
| 03665772000022 | K191878 | 000 |
| 03665772000039 | K191878 | 000 |
| 03665772000046 | K191878 | 000 |
| 03665772000053 | K191878 | 000 |
| 03665772000060 | K191878 | 000 |
| 03665772000077 | K191878 | 000 |
| 03665772000084 | K191878 | 000 |
| 03665772000008 | K191878 | 000 |