# Senorx, Inc.

- Location (FDA's records): Aliso Viejo, CA
- FDA decisions: 30 (2000–2023): 30 510(k) clearances
- Product codes: KNW (9), NEU (7), GEI (6), JAQ (5), ITX (1), GDW (1), FZP (1)
- 510(k) review time since 2016: median 27 days, against 127 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 44 (19 its own); citations of its devices by later devices: 32 (19 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ellman Intl., Inc.: 4 (https://510kreport.com/company/ellman-intl)
- Ethicon Endo-Surgery, Inc.: 4 (https://510kreport.com/company/ethicon-endo-surgery)
- Sybron Corp.: 3 (https://510kreport.com/company/sybron)
- Interventional Concepts, Inc.: 2 (https://510kreport.com/company/interventional-concepts)
- Valleylab, Inc.: 2 (https://510kreport.com/company/valleylab)
- Proxima Therapeutics, Inc.: 2 (https://510kreport.com/company/proxima-therapeutics)
- Milex Products, Inc.: 1 (https://510kreport.com/company/milex-products)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Cianna Medical, Inc.: 1 (https://510kreport.com/company/cianna-medical)
- Best Medical International, Inc.: 1 (https://510kreport.com/company/best-medical-international)
- Bioform, Inc.: 1 (https://510kreport.com/company/bioform)
- Focal Therapeutics: 1 (https://510kreport.com/company/focal-therapeutics)
- Sanarus Medical, Inc.: 1 (https://510kreport.com/company/sanarus-medical)
- Medical Park Co., Ltd.: 1 (https://510kreport.com/company/medical-park)
- Bard Peripheral Vascular, Inc.: 1 (https://510kreport.com/company/bard-peripheral-vascular)

## Its most-cited devices
- K071229: Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy (2007), cited by 3
- K093512: Encor Breast Biopsy System (2009), cited by 3
- K012023: Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable (2001), cited by 2
- K040842: Senorx Biopsy Device II (2004), cited by 2
- K000060: Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007 (2000), cited by 2
- K051158: Encor 7 Gauge (2005), cited by 2

## Recent decisions
- K233220: EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (Oct 27, 2023)
- K210654: EnCor Breast Biopsy Probe with Rinse Tube (Mar 31, 2021)
- K161805: EnCor MRI Introducer Set, EnCor Probe Introducer (Jul 19, 2016)
- K131654: Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker (Jun 27, 2013)
- K093512: Encor Breast Biopsy System (Nov 20, 2009)
- K092323: Contura Cavity Maintenance Catheter (Aug 19, 2009)
- K082264: Contura Lumen Marker (Sep 12, 2008)
- K081085: Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GS (Aug 1, 2008)

Source page: https://510kreport.com/company/senorx