# K203013: AGNES

- Pathway: 510(k) (Traditional)
- Applicant: Agnes Medical Co., Ltd.
- Decided: Jul 14, 2022 after 651 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 28 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192728: Agnes, Agnes Medical Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K223805: Agnes (2023), 3 descendants of its own
- K242469: RFMagik Lite (2025), 2 descendants of its own
- K250217: AGNES Ultra (2025), 0 descendants of its own
- K243713: Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (2025), 0 descendants of its own

## Indications for use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K203013
Methodology: https://510kreport.com/methodology