# K212301: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Nov 15, 2021 after 115 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
Longest line of descent: 16 generations back to K936109 (1994). 125 ancestors in all.
No later device cites it as a predicate yet.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180149: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide, Covidien, LLC (2018) Summary page 4.
- K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance, Ethicon Endo-Surgery, LLC (2013) Summary page 4.

## Indications for use
The SonicisionTM 7 curved jaw cordless ultrasonic dissection device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, and other open and endoscopic procedures. The device can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the minimum mode. The device can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the maximum mode. The SonicisionTm 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures. The SonicisionTm reusable battery pack is a non-sterile, rechargeable, lithium-ion battery that provides power to compatible surgical devices. For full device indications for use, reference the indications for use statements of the compatible devices.

Source page: https://510kreport.com/device/K212301
Methodology: https://510kreport.com/methodology