510(k) · Cleared
Recalled · Class II · 2021Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Feb 23, 2017 as substantially equivalent to K132612 (Ethicon Endo-Surgery, LLC, 2013) after a 248-day review. Its family tree reaches back 3 generations to 2007. It has been recalled 2 times.
- Decided
- Feb 23, 2017
- Review
- 248 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K072177 (2007). 6 ancestors in all, the oldest K060245 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK072177 Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 2007 · Recalled
- 2 generations backK112033 Enseal G2 Tissus SealersEthicon Endo-Sugery, LLC · 2011 · Recalled
- 1 generation backK132612 Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic…Ethicon Endo-Surgery, LLC · 2013 · Recalled
- This deviceK161693 Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced…Stryker Sustainability Solutions · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072177 | Enseal Vessel Sealing and Hemostasis System | Surgrx, Inc. | 2007 | 1 |
| −2 | K112033 | Enseal G2 Tissus Sealers | Ethicon Endo-Sugery, LLC | 2011 | 5 |
| −1 | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace +… | Ethicon Endo-Surgery, LLC | 2013 | 1 |
| 0 (this device) | K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | Stryker Sustainability Solutions | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Summary page 4…te Devices: Model 510(k) 510(k) Title Original Manufacturer Number Number HARH23 HARH36 K132612 HARMONIC ACE+ Shears with Advanced Hemostasis Ethicon Endo-Surgery HARH45 Device Description: Reprocessed HARMONIC A… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2021 | Class II | Z-1327-2021 | Device Design | Product was distributed without receiving regulatory clearance. |
| May 8, 2018 | Class II | Z-2484-2018 | Device Design | Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 7 other devices also cite its predicate K132612.
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. 2017, 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 | — |
What is it indicated for?
The Reprocessed HARMONIC ACE®+7, S mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161693: Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161693
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026