510(k) · Cleared
ClearedReprocessed Ultrasonic Scalpels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Jun 6, 2005 as substantially equivalent to K980099 (Ethicon Endo-Surgery, Inc., 1998) and 1 other predicate after a 182-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jun 6, 2005
- Review
- 182 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925699 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK925699 Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993
- 2 generations backK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
- 1 generation backK993054 Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5…Ethicon Endo-Surgery, Inc. · 1999
- This deviceK043358 Reprocessed Ultrasonic ScalpelsAlliance Medical Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925699 | Harmonic Scalpel Laparosonic Clamp Coagulator Acc. | Ultracision, Inc. | 1993 | — |
| −2 | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −1 | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| 0 (this device) | K043358 | Reprocessed Ultrasonic Scalpels | Alliance Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Summary page 1…Common or Usual Name: Reprocessed Ultrasonic Scalpels ClassificationName: Ultrasonic Surgical Instruments Predicate device(s): K(980099, K993054 Ethicon Endo-Surgery (Ultracision) Device description: Reprocessed Ultrasonic Scalpels are hand-held instruments… | 1998 |
| * | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…Summary page 1…Common or Usual Name: Reprocessed Ultrasonic Scalpels ClassificationName: Ultrasonic Surgical Instruments Predicate device(s): K(980099, K993054 Ethicon Endo-Surgery (Ultracision) Device description: Reprocessed Ultrasonic Scalpels are hand-held instruments… | 1999 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K980099.
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.
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?
Reprocessed Ultrasonic Scalpels are indicated in general and endoscopic surgery to cut and coagulate soft tissue when hemostasis is desired with a minimal risk of burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043358: Reprocessed Ultrasonic Scalpels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043358
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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