510(k) · Cleared
ClearedReprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
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 Jul 3, 2024 as substantially equivalent to K233471 (Stryker Sustainability Solutions, 2024) and 1 other predicate after a 29-day review. Its family tree reaches back 12 generations to 1994.
- Decided
- Jul 3, 2024
- Review
- 29 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K932293 (1994). 69 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 8 generations between
- 3 generations backK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
- 2 generations backK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- 1 generation backK233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length…Stryker Sustainability Solutions · 2024
- This deviceK241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length…Stryker Sustainability Solutions · 2024
Show all 12 generations
- Root · 12 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 11 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 10 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 9 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 8 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 7 generations backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- 6 generations backK081129 Enseal…Surgrx, Inc. · 2008
- 5 generations backK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- 4 generations backK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- 3 generations backK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
- 2 generations backK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- 1 generation backK233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length…Stryker Sustainability Solutions · 2024
- This deviceK241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length…Stryker Sustainability Solutions · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −11 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −10 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −9 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −8 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −7 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| −6 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| −5 | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| −4 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
| −3 | K160554 | Enseal X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2016 | — |
| −2 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | 2020 | — |
| −1 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)… | Stryker Sustainability Solutions | 2024 | — |
| 0 (this device) | K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)… | Stryker Sustainability Solutions | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 9 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Summary page 6…Single-Use Reprocessed Ultrasonic Surgical Instruments N/A NLQ 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Ifi NLQ K200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm Iengw L… | 2024 |
| * | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Summary page 6…1 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Ifi NLQ K200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm Iengw LFL Device Description Summary 21 CFR 807.92(a)(4) delivery button… | 2020 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 13 of the 69 ancestors have a recall of any class.
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. 2024, 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 1100 Shears 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, pediatric, gynecologic, urologic,
thoracic, 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
Energy button with Advanced Hemostasis.
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/K241606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241606: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241606
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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