510(k) · Cleared
ClearedReprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Apr 15, 2019 after a 236-day review. The FDA summary names no predicate by number.
- Decided
- Apr 15, 2019
- Review
- 236 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NLQ device
- #1 K233471 Reprocessed HARMONIC 1100 Shears, 5mm…score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NLQ devicesNLQ Single-Use Reprocessed Ultrasonic Surgical Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NLQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLQ
94in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLQ
44in 2025
MAUDE reports naming product code NLQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 1 | 25 |
| 2009 | 1 | — | 0 | 12 |
| 2010 | 2 | — | 0 | 33 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 1 | — | 0 | 113 |
| 2013 | 0 | — | 0 | 111 |
| 2014 | 3 | 303 | 0 | 63 |
| 2015 | 2 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 72 |
| 2017 | 3 | 94 | 0 | 87 |
| 2018 | 1 | — | 0 | 56 |
| 2019 | 2 | — | 0 | 45 |
| 2020 | 1 | — | 0 | 28 |
| 2021 | 1 | — | 0 | 40 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 0 | — | 1 | 16 |
| 2024 | 2 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K182272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182272: Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182272
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026