# Serpex Medical, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 5 (2022–2026): 5 510(k) clearances
- Names in FDA's records: Serpex Medical, Inc. (3); Serpex Medical (2)
- Product codes: KTI (2), GEH (2), EOQ (1)
- 510(k) review time since 2016: median 90 days, against 137 for FDA's reviews in the same codes and years (5 of 5 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Erbe Elektromedizin GmbH: 2 (https://510kreport.com/company/erbe-elektromedizin)
- Olympus Surgical Technologies America: 1 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)
- Bodyvision Medical, Ltd.: 1 (https://510kreport.com/company/bodyvision-medical)

## Its most-cited devices
- K221206: Compass Steerable Needle (2022), cited by 1

## Recent decisions
- K262420: Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) (Sep 2, 2026)
- K261068: Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (Jun 30, 2026)
- K252874: Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (Oct 8, 2025)
- K221206: Compass Steerable Needle (Aug 25, 2022)
- K221302: Recon Steerable Sheath (Aug 15, 2022)

Source page: https://510kreport.com/company/serpex-medical