FDA product code LFL: Instrument, Ultrasonic Surgical
LFL is the FDA product code for instrument, ultrasonic surgical. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 158 510(k) submissions under LFL, 19 in the last five years, from 74 different applicants. The average 510(k) review took 123 days (median 90); 153 days on average over the last three years. FDA has posted 109 recalls for LFL devices, 28 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Ultrasonic Surgical |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LFL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 29 |
| 2018 | 3 | 76 |
| 2019 | 4 | 132 |
| 2020 | 4 | 183 |
| 2021 | 6 | 111 |
| 2022 | 8 | 206 |
| 2023 | 4 | 131 |
| 2024 | 3 | 189 |
| 2025 | 3 | 179 |
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every LFL clearance
Top LFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ethicon Endo-Surgery, Inc. | 15 | 2006-09-25 |
| Ethicon Endo-Surgery, LLC | 14 | 2023-02-28 |
| Integra LifeSciences Corporation | 12 | 2025-10-08 |
| Misonix, Inc. | 10 | 2022-07-28 |
| Valleylab, Inc. | 9 | 1998-07-06 |
69 more applicants have LFL clearances. See the full list in Caduvo.
Most recent LFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261448 | Misonix, LLC | neXus Ultrasonic Surgical Aspirator System | 2026-07-30 | 90 |
| K251162 | Integra LifeSciences Corporation | CUSA® Clarity Ultrasonic Surgical Aspirator System | 2025-10-08 | 176 |
| K242894 | Shanghai Saints Sages Surgical Co., Ltd. | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) | 2025-06-18 | 268 |
| K243930 | Stryker Instruments | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | 2025-03-24 | 94 |
| K241700 | Trice Medical, Inc. | Tenex 2nd Generation System | 2024-11-18 | 158 |
Recalls for LFL devices
109 product recalls in 32 recall events; 28 initiated in the last five years and 30 still open. Most recent: 2026-03-06.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 42 |
| 2021 | 4 |
| 2023 | 2 |
| 2024 | 12 |
| 2025 | 12 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LFL?
LFL is the FDA product code for instrument, ultrasonic surgical. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is LFL?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFL?
Across 158 cleared submissions the average was 123 days from receipt to decision (median 90).
Which companies have the most LFL clearances?
Ethicon Endo-Surgery, Inc. (15); Ethicon Endo-Surgery, LLC (14); Integra LifeSciences Corporation (12); Misonix, Inc. (10); Valleylab, Inc. (9).
Have LFL devices been recalled?
Yes: 109 product recalls across 32 recall events; the most recent began 2026-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code LFL
- Run a recall and safety report across every LFL manufacturer
- Watch product code LFL 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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