The following data is part of a premarket notification filed by Schoelly Fiberoptic, Gmbh with the FDA for Schoelly Nephroscope Set, Schoelly Ultra-mini Nephroscope Set.
| Device ID | K151308 |
| 510k Number | K151308 |
| Device Name: | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set |
| Classification | Kit, Nephroscope |
| Applicant | SCHOELLY FIBEROPTIC, GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE 79211 |
| Contact | Sandra Baumann |
| Correspondent | Sandra Baumann SCHOELLY FIBEROPTIC, GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE 79211 |
| Product Code | FGA |
| Subsequent Product Code | FEC |
| Subsequent Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2016-02-09 |
| Summary: | summary |