# LBK: Neurosurgical Ultrasonic Instruments

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1985: 1
- 1986: 1
- 1988: 3
- 1996: 1
- 1997: 1

## Most-cited predicates
- K962952: Olympus Ultrasonic Surgical System (Usu) (1996), cited by 3
- K884413: Cusa System 200H Ultrasonic Surgical Aspirator (1988), cited by 3
- K853143: Cooper Laser Sonics Cusa Model 200 (1985), cited by 2
- K884412: Cusa System 200C,T & M Ultrasonic Surgical Aspira. (1988), cited by 2
- K855138: Bovie Ultrasonic Surgical System (1986), cited by 1

Source page: https://510kreport.com/product-code/LBK
Data by year (CSV): https://510kreport.com/product-code/LBK.csv