# K973249: Endoassist

- Pathway: 510(k) (Traditional)
- Applicant: Armstrong Healthcare, Ltd.
- Decided: Nov 26, 1997 after 89 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: 1 generation back to K922626 (1992). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931783: Aesop (Automated Endoscopic System for Optimal Pos, Computer Motion, Inc. (1993) Summary page 1.
- K922626: Adept Instrument Positioning Accessory, Andronic Devices, Ltd. (1992) Summary page 1.

## Most influential descendants
- K043284: Endoassist (2005), 2 descendants of its own
- K090340: Freehand (2009), 1 descendant of its own
- K102179: Enview (TM) (2010), 0 descendants of its own

## Indications for use
Endo Assist positions a Laparoscope and is indicated for use in laparoscopic thoracoscopic and pelvic procedures including laparoscopic cholecystectomy hernia repair Fundoplication Splenectomy appendectomy hemicolectomy <2n(«bhe d:on)l Lymph node dissection hg(tuccton/ hv)f<’°“"°r,‘

Source page: https://510kreport.com/device/K973249
Methodology: https://510kreport.com/methodology