The following data is part of a premarket notification filed by Endomedix with the FDA for Stone Retrieval Basket.
| Device ID | K930349 |
| 510k Number | K930349 |
| Device Name: | STONE RETRIEVAL BASKET |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Leigh Weintraub |
| Correspondent | Leigh Weintraub ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-25 |
| Decision Date | 1993-06-09 |