# K232033: HYBRIDknife® flex

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Nov 29, 2023 after 145 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: 9 generations back to K952726 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083608: Erbe Hybrid Knife, Erbe USA, Inc. (2009) Summary page 4.
- K231023: ERBEJET® 2 System, Erbe Elektromedizin GmbH (2023) Summary page 4.

## Indications for use
The HYBRIDknife flex is intended for: • monopolar cutting and coagulation. • needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue). The HYBRIDknife flex is used in endoscopic interventions.

Source page: https://510kreport.com/device/K232033
Methodology: https://510kreport.com/methodology