NLQ

27 FDA 510(k) clearances · Product code

FDA profile

Official device name

Single-Use Reprocessed Ultrasonic Surgical Instruments

Device class

Unclassified

Medical specialty

Unknown

FDA definition

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Adverse events (MAUDE)

2021: 40 · 2022: 31 · 2023: 16 · 2024: 19 · 2025: 44 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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