ULTRASONIC LITHOTRIPTOR 300A— 510(k) K842024
Substantially EquivalentFibra Sonics, Inc.
FDA 510(k) clearance K842024 for ULTRASONIC LITHOTRIPTOR 300A, Substantially Equivalent on 1984-12-11. Applicant: Fibra Sonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Fibra Sonics, Inc.
- Product code
- Code FEO
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code FEO
view allMore clearances from Fibra Sonics, Inc.
view all- K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
- K984199 — EXONIX
- K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
- K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
- K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
Adverse events under product code FEO
product code FEO- Malfunction
- 910
- Other
- 1
- Total
- 911
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.