510(k) Report

FDA applicant

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

Indianapolis, IN1 decision2017–20170 recalls

FDA records 1 decision for Ths International, Inc. D/B/A Accordion Medical (Indianapolis, IN) in 2017: 1 510(k) clearance. All are in product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Ths International, Inc. D/B/A Accordion Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ths International, Inc. D/B/A Accordion Medical by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FFLDislodger, Stone, Basket, Ureteral, Metal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017

The one decision as Ths International, Inc. D/B/A Accordion Medical →