# K043284: Endoassist

- Pathway: 510(k) (Traditional)
- Applicant: Armstrong Healthcare Limited
- Decided: Feb 25, 2005 after 91 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: 5 generations back to K931783 (1993). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973249: Endoassist, Armstrong Healthcare, Ltd. (1997) Summary page 1.
- K972699: Aesop 3000 System and Accessories, Computer Motion, Inc. (1997) Summary page 1.
- K023735: Lapman Laparoscope Manipulator System and Accessories, Model 900-001, Medsys, S.A. (2003) Summary page 1.

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

## Indications for use
EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use. A few examples of the more common endoscopic surgeries are laparoscopic* cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding gastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy, internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair. The users of EndoAssist are general surgeons, bariatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons and urologists * In this context "laparoscopic" is taken to embrace the use of a rigid endoscope in any part of the body

Source page: https://510kreport.com/device/K043284
Methodology: https://510kreport.com/methodology