Single-Use Reprocessed Ultrasonic Surgical Instruments
NLQ is the FDA product code for Single-Use Reprocessed Ultrasonic Surgical Instruments. FDA's definition for this code reads: "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...". As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- NLQ
- Device name
- Single-Use Reprocessed Ultrasonic Surgical Instruments
- FDA 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).
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 27
- Ingested recalls
- 7
Clearances, product code NLQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 1 |
| 2005 | 4 |
| 2009 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Applicants with the most clearances
Product code NLQ| Applicant | Clearances |
|---|---|
| Stryker Sustainability Solutions | 11 |
| Sterilmed Inc | 8 |
| Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2 |
| Alliance Medical Corp. | 1 |
| Medisiss | 1 |
| Medline ReNewal | 1 |
| Surgical Instrument Services and Savings(Dba Medline Renewal | 1 |
| Surgical Instrument Services and Savings, Inc. | 1 |
| Surgical Instruments Service and Savings, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
