510(k) · Cleared
ClearedReprocessed Ultrasonic Coagulating Shears
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Mar 4, 2010 as substantially equivalent to K062000 (Ethicon Endo-Surgery, Inc., 2006) after a 93-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Mar 4, 2010
- Review
- 93 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062000 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062000 Harmonic Wave Coagulating Shears with Scissor Handel and Hand…Ethicon Endo-Surgery, Inc. · 2006
- This deviceK093702 Reprocessed Ultrasonic Coagulating ShearsAscent Healthcare Solutions · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062000 | Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model… | Ethicon Endo-Surgery, Inc. | 2006 | — |
| 0 (this device) | K093702 | Reprocessed Ultrasonic Coagulating Shears | Ascent Healthcare Solutions | 2010 | — |
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 |
|---|---|---|---|
| * | K062000 | Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S…Summary page 1…Shears Classification Name: Scalpel, Ultrasonic, Reprocessed Predicate Device 510(k) Title Manufacturer K062000 Harmonic Wave Coagulating Shears Ethicon Endo-Surgery, With Scissor Handle and… | 2006 |
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.
What does this lineage say?
- Its one ancestor has no 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. 2010, 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 Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093702: Reprocessed Ultrasonic Coagulating Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093702
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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