# K102839: Spider Standard and Advanced

- Pathway: 510(k) (Special)
- Applicant: Transenterix, Inc.
- Decided: Mar 15, 2011 after 167 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940232 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003, Transenterix, Inc. (2009) Summary page 1.

## Recalls of this device
- Feb 25, 2011 · Not classified · Z-1910-2011: Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.

## Indications for use
The SPIDER TM (Single Port Instrument Delivery Extended Reach) devices are intended to establish a path of entry for laparoscopic instruments for minimally invasive abdominal surgical procedures.

Source page: https://510kreport.com/device/K102839
Methodology: https://510kreport.com/methodology