# Human Xtensions, Ltd.

- Location (FDA's records): Netanya, IL
- FDA decisions: 5 (2021–2023): 5 510(k) clearances
- Product codes: GCJ (5)
- 510(k) review time since 2016: median 76 days, against 109 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 3 (3 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
- Human Extension, Ltd.: 3 (https://510kreport.com/company/human-extension)
- Covidien Lp, Formerly Registered AS United States: 1 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)

## Its most-cited devices
- K203603: Monopolar Hook (2021), cited by 3

## Recent decisions
- K223718: HandX™ Self-Righting Needle Holder (Jun 5, 2023)
- K230491: HandX™ Monopolar Scissors (May 10, 2023)
- K222011: HandX Instrument - Monopolar Spatula (Jan 12, 2023)
- K212214: HandX (Sep 13, 2021)
- K203603: Monopolar Hook (Feb 1, 2021)

Source page: https://510kreport.com/company/human-xtensions