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Single-Use Reprocessed Ultrasonic Surgical Instruments

FDA product code NLQ · 22 cleared devices

Class U Unknown
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2001-11-07 – 2025-08-14

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).

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