# K971861: Ultrasonic Hand Instruments

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jul 1, 1997 after 42 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
269 later devices descend from it; 3 cite it directly.
1 of 270 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K961104: Notebook Imager, Digirad Corp. (1997). Our OCR of the scanned summary read K961104, FDA’s number for Notebook Imager (Digirad Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ethicon Ultracision ultrasonic hand instruments”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K980099: Ultracision  Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) (1998), 268 descendants of its own
- K993054: Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 (1999), 263 descendants of its own
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument (2004), 235 descendants of its own
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 229 descendants of its own
- K043288: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 229 descendants of its own

## Indications for use
The AUTO SUTURE? ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.

Source page: https://510kreport.com/device/K971861
Methodology: https://510kreport.com/methodology