# K943327: Conmed Selectone Minimal Access Surgery Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Nov 7, 1994 after 118 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 12, 2006 · Not classified · Z-0094-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0096-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0101-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0103-2007: The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no in
- Oct 12, 2006 · Not classified · Z-0112-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0113-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0114-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0093-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0108-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0109-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0097-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0100-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0102-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0105-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0106-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0107-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0095-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0098-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0099-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0104-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0110-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Oct 12, 2006 · Not classified · Z-0111-2007: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

Source page: https://510kreport.com/device/K943327
Methodology: https://510kreport.com/methodology