# K221102: LOTUS Series 4 Enhanced Shears, LOTUS Series 5

- Pathway: 510(k) (Traditional)
- Applicant: Sra Developments, Ltd.
- Decided: Dec 15, 2022 after 245 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: 5 generations back to K900003 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151101: Lotus Series 4 Ultrasonic Surgical System & Accessories, Sra Developments, Ltd. (2015) Summary page 4.

## Indications for use
LOTUS Series 4 Enhanced Shears LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. They may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint). LOTUS Series 5 The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

Source page: https://510kreport.com/device/K221102
Methodology: https://510kreport.com/methodology