# K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Medivators (A Subsidiary of Steris Corporation)
- Decided: Dec 21, 2023 after 140 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 6 generations back to K944759 (1995). 21 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102409: Defendo Disposable Air/Water Valve Model 100304, Byrne Medical, Inc. (2010) Summary page 6.
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 6.
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor, STERIS Corporation (2021) Summary page 6.
- K220395: EndoGator Endoscopy Irrigation Tubing, STERIS Corporation (2022) Summary page 6.
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 6.

## Most influential descendants
- K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (2024), 1 descendant of its own
- K250140: Defendo Fujifilm 700 Single Use Cleaning Adapter (2025), 0 descendants of its own
- K243075: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (2024), 0 descendants of its own

## Indications for use
The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit). The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

Source page: https://510kreport.com/device/K232329
Methodology: https://510kreport.com/methodology