# K092090: Erbelift Hand Pump and Flexible Probe

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Nov 30, 2009 after 139 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924102 (1992). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924102: Needle, United States Endoscopy Group, Inc. (1992) Summary page 1.
- K040961: Injector Needle/Snare, United States Endoscopy Group, Inc. (2004) Summary page 1.

## Most influential descendants
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (2015), 12 descendants of its own
- K171158: Single Use Electrosurgical knife (2017), 7 descendants of its own
- K243120: HybridAPC probe (2025), 1 descendant of its own
- K231023: ERBEJET® 2 System (2023), 1 descendant of its own
- K193601: Single Use Electrosurgical Knife (2020), 1 descendant of its own

## Indications for use
The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.

Source page: https://510kreport.com/device/K092090
Methodology: https://510kreport.com/methodology