# K012833: Intuitive Surgical Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Nov 16, 2001 after 85 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912544 (1991). 8 ancestors in all.
233 later devices descend from it; 6 cite it directly.
1 of 242 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991859: Dexide Bipolar Forceps II ** Device, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.

## Most influential descendants
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 229 descendants of its own
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 228 descendants of its own
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000 (2006), 224 descendants of its own
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), 211 descendants of its own
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182 (2006), 155 descendants of its own

## Recalls of this device
- May 8, 2013 · Class II · Z-1432-2013: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Inst
- May 8, 2013 · Class II · Z-1431-2013: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Inst
- May 8, 2013 · Class II · Z-1433-2013: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Inst
- Mar 24, 2005 · Not classified · Z-0660-2007: The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.

## Indications for use
The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vinci™ Surgical System to grasp, retract, coagulate and transect soft tissues during endoscopic surgical procedures.

Source page: https://510kreport.com/device/K012833
Methodology: https://510kreport.com/methodology