The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Spiral Stone And Retrieval Baskets.
| Device ID | K820429 |
| 510k Number | K820429 |
| Device Name: | SPIRAL STONE AND RETRIEVAL BASKETS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-17 |
| Decision Date | 1982-04-08 |