510(k) · Cleared
ClearedMedline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Jul 3, 2017 as substantially equivalent to K101797 (Covidien, Formerly Valleylab, A Division of Tyco, 2011) after a 94-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Jul 3, 2017
- Review
- 94 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K970720 (1997). 35 ancestors in all, the oldest K821994 (1982). No later device cites it as a predicate yet.
- Root · 8 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 7 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 6 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 5 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 4 generations backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- 3 generations backK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- 2 generations backK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
- 1 generation backK101797 Sonicision Cordless Ultrasonic Dissection Device Model SCD391…Covidien, Formerly Valleylab, A Division of Tyco · 2011
- This deviceK170955 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −7 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −6 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −5 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| −4 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| −3 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| −2 | K071708 | I45, I45S, I60, and I60S | Power Medical Interventions, Inc. | 2007 | 1 |
| −1 | K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12… | Covidien, Formerly Valleylab, A Division of Tyco | 2011 | — |
| 0 (this device) | K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Summary page 5…Product Code: NLQ Panel: General & Plastic Surgery 510(k) Number: K101797 Propriety/Trade Name: Sonicision Cordless Ultrasonic Dissection… | 2011 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 7 of the 35 ancestors have a recall of any class.
- 3 other devices also cite its predicate K101797.
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 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices 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 (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.
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/K170955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170955: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170955
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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