Data / Medical devices / United States / Serpex Medical, Inc.
Serpex Medical, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 4 510(k) clearances
Serpex Medical, Inc. is registered with the FDA (registration 3026787544) in Santa Clara, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3026787544
- Address
- 3350 Scott Blvd Suite 37B, Santa Clara, CA, United States, 95054
- Owner or operator
- Serpex Medical, Inc. (10087569)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 3, 2025
- Registered through
- 2027
- Brand names listed
- Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01, Recon Steerable Sheath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 2, 2026 | K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | GEH | Substantially Equivalent | Serpex Medical | accessdata.fda.gov |
| June 30, 2026 | K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | GEH | Substantially Equivalent | Serpex Medical | accessdata.fda.gov |
| October 8, 2025 | K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | KTI | Substantially Equivalent | Serpex Medical, Inc. | accessdata.fda.gov |
| August 15, 2022 | K221302 | Recon Steerable Sheath | EOQ | Substantially Equivalent | Serpex Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope Accessory
- All makers of Unit, Cryosurgical, Accessories
- All makers of Bronchoscope (Flexible Or Rigid)
Updated September 2, 2026. 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.