NLQ
- 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).
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250898 | 2025-08-14 | Stryker Sustainability Solutions | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed | |
| K241606 | 2024-07-03 | Stryker Sustainability Solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm | |
| K233471 | 2024-02-20 | Stryker Sustainability Solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm |
Official FDA classification page: NLQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).