# K070509: Fisso Holding System

- Pathway: 510(k) (Traditional)
- Applicant: Baitella AG
- Decided: Mar 22, 2007 after 28 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 3 generations back to K945572 (1995). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050051: Armand Endoscope Holder, KLS-Martin L.P. (2005) Summary page 1.
- K992006: Neuroview Instrument Holder, Model 300-33, Integra Neurocare, LLC (1999) Summary page 1.
- K950214: Abdominal Wall Retractor, Omni-Tract Surgical, Div. Minn. Scientific, Inc. (1995) Summary page 1.

## Most influential descendants
- K190576: WalterLorenz Surgical Assist Arm Scope Holder (2019), 2 descendants of its own
- K240506: KARL STORZ Holders (2024), 0 descendants of its own
- K232405: Endofix Exo (2024), 0 descendants of its own
- K100442: Fastclamp Endoscopic Clamping System (2010), 0 descendants of its own

## Indications for use
FISSO Holding System consists of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 4mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.

Source page: https://510kreport.com/device/K070509
Methodology: https://510kreport.com/methodology