# K951589: Manual Surgical Insrument

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: May 3, 1995 after 27 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
75 later devices descend from it; 5 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K072814: Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures (2008), 59 descendants of its own
- K082619: Sils Port, Models SILSPT5, SILSPT12 (2008), 58 descendants of its own
- K091869: Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears (2009), 52 descendants of its own
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003 (2009), 46 descendants of its own
- K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories (2011), 43 descendants of its own

Source page: https://510kreport.com/device/K951589
Methodology: https://510kreport.com/methodology