510(k) · Cleared
ClearedUltracision 5MM Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Oct 21, 1998 after a 30-day review. The FDA summary names no predicate by number. 84 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 30 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
84 later devices descend from it, 2 citing it directly.
- This deviceK983316 Ultracision 5MM InstrumentsEthicon Endo-Surgery, Inc. · 1998
- Descendant · cites it directly · 49 of its ownK993868 The Soundvaser Dissection SystemSound Surgical Technologies, LLC · 1999 · Recalled
- Descendant · 2 generations on · 48 of its ownK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- Descendant · 3 generations on · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · 4 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · cites it directly · 33 of its ownK990362 Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K993868The Soundvaser Dissection SystemSound Surgical Technologies, LLC · 1999 · cites it directly49descendants
- K022051Soundvaser SystemSound Surgical Technologies, LLC · 2002 · 2 generations on48descendants
- K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · 3 generations on36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 4 generations on34descendants
- K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999 · cites it directly33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983316 | Ultracision 5MM Instruments | Ethicon Endo-Surgery, Inc. | 1998 | — |
| +1 | K993868 | The Soundvaser Dissection System | Sound Surgical Technologies, LLC | 1999 | 2 |
| +2 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| +3 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +4 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +1 | K990362 | Instrument, Ultrasonic, Scalpel | Ethicon Endo-Surgery, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 9 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (84)
See all 842 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K993868 (Sound Surgical Technologies, LLC, 1999) has gone furthest, with 49 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The UltraCision Smm Instruments 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, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
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/K983316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983316: Ultracision 5MM Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983316
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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