Data / Medical devices / United States / CoapTech, Inc.
CoapTech, Inc.: FDA-registered device maker in Baltimore, MD, United States, 2 510(k) clearances
CoapTech, Inc. is registered with the FDA (registration 3015177732) in Baltimore, MD, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015177732
- Address
- 101 W. Dickman Street, Suite 700, Baltimore, MD, United States, 21230
- Owner or operator
- CoapTech (10058608)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- February 22, 2024
- Registered through
- 2026
- Brand names listed
- PUMA-G Pediatric System, PUMA-G System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tube, Gastro-Enterostomy | KGC | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 29, 2025 | K242211 | PUMA-G Pediatric System | KGC | Substantially Equivalent | Coaptech, Inc. | accessdata.fda.gov |
| March 29, 2023 | K223916 | PUMA-G System | KGC | Substantially Equivalent | Coaptech, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 29, 2025. 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.