NLQ

Single-Use Reprocessed Ultrasonic Surgical Instruments

Product code
NLQ
Device name
Single-Use Reprocessed Ultrasonic Surgical Instruments
Device class
Class U
Medical specialty
Unknown
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
27 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-08-14.

NumberDecision dateApplicantDevice nameSummary
K2508982025-08-14Stryker Sustainability SolutionsReprocessed HARMONIC 700 Shears (HAR723/Reprocessed PDF
K2416062024-07-03Stryker Sustainability SolutionsReprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cmPDF
K2334712024-02-20Stryker Sustainability SolutionsReprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cmPDF

3 summaries are archived here for direct download.

Official FDA classification page: NLQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).