Data / Medical devices / United States / Adapta Medical, Inc.
Adapta Medical, Inc.: FDA-registered device maker in Colorado Springs, CO, United States, 1 510(k) clearance
Adapta Medical, Inc. is registered with the FDA (registration 3008772421) in Colorado Springs, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008772421
- Address
- 142 Talamine Ct, Colorado Springs, CO, United States, 80907
- Owner or operator
- Adapta Medical, Inc (10033957)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 3, 2017
- Registered through
- 2026
- Brand names listed
- PerfIC Cath Gel-S, PerfIC Cath Hydro-C, PerfIC Cath Hydro-S, mPower Cath Hydro-C, mPower Cath Hydro-S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Straight | EZD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 16, 2016 | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | EZD | Substantially Equivalent | Adapta Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 16, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.