The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Loop Retriever.
| Device ID | K910603 |
| 510k Number | K910603 |
| Device Name: | LOOP RETRIEVER |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
| Contact | Stuart J Lind |
| Correspondent | Stuart J Lind ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-03-11 |