LBK
7 FDA 510(k) clearances · Product code
79 daysmedian time to decision
322 days90th percentile
7clearances measured
FDA profile
- Official device name
- Neurosurgical Ultrasonic Instruments
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 2003: 2 · 2005: 3 · 2006: 7 · 2007: 3 · 2013: 16 · 2014: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DISSECTRON PORTABLE UNIT (K972612) | Satelec | 1997-10-08 |
| OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (K962952) | Olympus Optical, Co. | 1996-11-29 |
| CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (K884413) | Valleylab, Inc. | 1988-12-02 |
| CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (K884412) | Valleylab, Inc. | 1988-12-02 |
| AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (K883522) | Amerimed US Corp. | 1988-09-30 |
| BOVIE ULTRASONIC SURGICAL SYSTEM (K855138) | Clinical Technology Corp. | 1986-11-10 |
| COOPER LASER SONICS CUSA MODEL 200 (K853143) | Cooper Lasersonics, Inc. | 1985-10-16 |
Track LBK automatically
Every clearance here is in the API, with alerts when new ones post.