The following data is part of a premarket notification filed by Percutaneous Systems, Inc. with the FDA for Accordion Stone Management Device Model Ac281205 And Ac3814510.
| Device ID | K102887 |
| 510k Number | K102887 |
| Device Name: | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | PERCUTANEOUS SYSTEMS, INC. 3260 HILLVIEW AVE. Palo Alto, CA 94304 |
| Contact | Thomas Lawson, Phd |
| Correspondent | Thomas Lawson, Phd PERCUTANEOUS SYSTEMS, INC. 3260 HILLVIEW AVE. Palo Alto, CA 94304 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-05-16 |
| Summary: | summary |