Urolution Medical, Inc. FDA Record
- No warning letters matched by name
Urolution Medical, Inc. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Urolution Medical, Inc." is on file.
- Latest 510(k)
- Oct 6, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 1 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Urolution Medical, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Urolution Medical, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K261141 | OpenFlo Urinary Catheter | Oct 6, 2026 |
Urolution Medical, Inc. and the FDA: common questions
Has Urolution Medical, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Urolution Medical, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Urolution Medical, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Urolution Medical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
Need more than this page shows? Ask about Urolution Medical, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.