The following data is part of a premarket notification filed by Ths International, Inc. D/b/a Accordion Medical with the FDA for Accordion Piccolo Stone Management Device.
| Device ID | K172299 |
| 510k Number | K172299 |
| Device Name: | Accordion Piccolo Stone Management Device |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | THS International, Inc. D/b/a Accordion Medical 9465 Counselors Row, Suite 200 Indianapolis, IN 46240 |
| Contact | David Quigley |
| Correspondent | David Quigley THS International, Inc. D/b/a Accordion Medical 9465 Counselors Row, Suite 200 Indianapolis, IN 46240 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-31 |
| Decision Date | 2017-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857252004030 | K172299 | 000 |