The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Stone Retrieval Baskets.
| Device ID | K012581 |
| 510k Number | K012581 |
| Device Name: | REPROCESSED STONE RETRIEVAL BASKETS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | STERILMED, INC. 11400 73RD AVE N., SUITE 100 Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 11400 73RD AVE N., SUITE 100 Maple Grove, MN 55369 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2002-02-14 |
| Summary: | summary |