Accordion Piccolo Stone Management Device— 510(k) K172299

Substantially Equivalent

Ths International, Inc. D/B/A Accordion Medical

FDA 510(k) clearance K172299 for Accordion Piccolo Stone Management Device, Substantially Equivalent on 2017-09-19. Applicant: Ths International, Inc. D/B/A Accordion Medical.

Clearance details

Applicant: Ths International, Inc. D/B/A Accordion Medical
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 2017-07-31
Decision date: 2017-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.