510(k) · Cleared
Recalled · 2008Reprocessed Harmonic Scalpels
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 12, 2005 as substantially equivalent to K941897 (Ultracision, Inc., 1994) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 2 times.
- Decided
- Apr 12, 2005
- Review
- 60 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930352 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930352 Harmonic Scalpel Reusable Laporascopic Blade Syst.Ultracision, Inc. · 1993
- This deviceK050343 Reprocessed Harmonic ScalpelsSterilmed, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930352 | Harmonic Scalpel Reusable Laporascopic Blade Syst. | Ultracision, Inc. | 1993 | — |
| 0 (this device) | K050343 | Reprocessed Harmonic Scalpels | Sterilmed, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K941897 | Ultracison Harmonic Scalpel HS2 BladeSummary page 4…NLQ Predicate Device(s): The reprocessed harmonic scalpels are substantially equivalent to Harmonic Scalpel Hs2 Blade (K941897), manufactured by Ethicon (formerly Ultracision) and Reusable… | 1994 |
| * | K930352 | Harmonic Scalpel Reusable Laporascopic Blade Syst.Summary page 4…lade (K941897), manufactured by Ethicon (formerly Ultracision) and Reusable Laparosonic Blade System (K930352), manufactured by Ethicon (formerly Ultracision). Device Description: Harmonic s… | 1993 |
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 |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0549-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
| Aug 8, 2008 | Not classified | Z-0559-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K941897.
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?
The reprocessed harmonic scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050343: Reprocessed Harmonic Scalpels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050343
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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