# K090340: Freehand

- Pathway: 510(k) (Special)
- Applicant: Prosurgics Limited
- Decided: May 22, 2009 after 101 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: 6 generations back to K931783 (1993). 8 ancestors in all.
1 later device descends 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)
- K043284: Endoassist, Armstrong Healthcare Limited (2005) Summary page 1.
- K972699: Aesop 3000 System and Accessories, Computer Motion, Inc. (1997) Summary page 1.

## Most influential descendants
- K102179: Enview (TM) (2010), 0 descendants of its own

## Indications for use
Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscopeis intended for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectormy 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

Source page: https://510kreport.com/device/K090340
Methodology: https://510kreport.com/methodology