Preceptis Medical, Inc
Golden Valley, MN, US
PRECEPTIS MEDICAL, INC appears in FDA device records in Golden Valley, MN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Preceptis Medical, Inc between 2014 and 2022. The busiest year on record is 2015, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221254 | Hummingbird Tympanostomy Tube System | ETD | Substantially Equivalent | |
| K200952 | Hummingbird Tympanostomy Tube System | ETD | Substantially Equivalent | |
| K151830 | Hummingbird Tympanostomy Tube | ETD | Substantially Equivalent | |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | ETD | Substantially Equivalent | |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | ETD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010610937 | 3010610937 | PRECEPTIS MEDICAL, INC | 8401 Wayzata Blvd, Golden Valley, MN 55426 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain