FDA product code NLQ: Single-Use Reprocessed Ultrasonic Surgical Instruments
NLQ is the FDA product code for single-use reprocessed ultrasonic surgical instruments. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 27 510(k) submissions under NLQ, 3 in the last five years, from 11 different applicants. The average 510(k) review took 171 days (median 155); 108 days on average over the last three years. FDA has posted 7 recalls for NLQ devices, 3 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | Single-Use Reprocessed Ultrasonic Surgical Instruments |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for NLQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 130 |
| 2018 | 1 | 230 |
| 2019 | 2 | 196 |
| 2020 | 1 | 240 |
| 2021 | 1 | 194 |
| 2024 | 2 | 74 |
| 2025 | 1 | 142 |
Compare with all 510(k) review times · Search every NLQ clearance
Top NLQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 8 | 2019-08-15 |
| Stryker Sustainability Solutions | 7 | 2025-08-14 |
| Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2 | 2020-08-19 |
| Ascent Healthcare Solutions | 2 | 2010-05-12 |
| Vanguard Medical Concepts, Inc. | 2 | 2005-03-22 |
6 more applicants have NLQ clearances. See the full list in Caduvo.
Most recent NLQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250898 | Stryker Sustainability Solutions | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | 2025-08-14 | 142 |
| K241606 | Stryker Sustainability Solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | 2024-07-03 | 29 |
| K233471 | Stryker Sustainability Solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | 2024-02-20 | 118 |
| K202554 | Stryker Sustainability Solutions | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | 2021-03-16 | 194 |
| K193563 | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | 2020-08-19 | 240 |
Recalls for NLQ devices
7 product recalls in 7 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-09-24.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NLQ?
NLQ is the FDA product code for single-use reprocessed ultrasonic surgical instruments. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is NLQ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLQ?
Across 27 cleared submissions the average was 171 days from receipt to decision (median 155).
Which companies have the most NLQ clearances?
Sterilmed, Inc. (8); Stryker Sustainability Solutions (7); Surgical Instrument Service and Savings Inc.(Dba Medline Ren (2); Ascent Healthcare Solutions (2); Vanguard Medical Concepts, Inc. (2).
Have NLQ devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2025-09-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NLQ
- Run a recall and safety report across every NLQ manufacturer
- Watch product code NLQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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