510(k) · Cleared
ClearedUltrasonic Hand Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · LFL Instrument, Ultrasonic Surgical
Cleared on Jul 1, 1997 after a 42-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 270 devices in its family, counting itself, has a Class I recall. 269 later devices descend from it.
- Decided
- Jul 1, 1997
- Review
- 42 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
269 later devices descend from it, 3 citing it directly. 1 of the 270 devices in this family, counting this one, has a Class I recall.
- This deviceK971861 Ultrasonic Hand InstrumentsUnited States Surgical, A Division of Tyco Healthc · 1997
- Descendant · cites it directly · 268 of its ownK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
- Descendant · 2 generations on · 263 of its ownK993054 Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5…Ethicon Endo-Surgery, Inc. · 1999
- Descendant · 3 generations on · 235 of its ownK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
- Descendant · 4 generations on · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- Descendant · 4 generations on · 229 of its ownK043288 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
Showing 5 of 269 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System6 generations on · 2023
Most influential descendants
Showing 5 of 269 · See all- K980099Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998 · cites it directly268descendants
- K993054Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…Ethicon Endo-Surgery, Inc. · 1999 · 2 generations on263descendants
- K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004 · 3 generations on235descendants
- K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 4 generations on229descendants
- K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 4 generations on229descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971861 | Ultrasonic Hand Instruments | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| +1 | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| +2 | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +3 | K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | Intuitive Surgical, Inc. | 2004 | — |
| +4 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| +4 | K043288 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 17 | 0 |
| 2018 | 19 | 0 |
| 2019 | 10 | 0 |
| 2020 | 18 | 0 |
| 2021 | 18 | 0 |
| 2022 | 20 | 0 |
| 2023 | 20 | 1 |
| 2024 | 22 | 0 |
| 2025 | 32 | 0 |
| 2026 | 23 | 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.
1 device in this family has a Class I recall. 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K961104 | FDA’s K961104 is Notebook Imager Our OCR of the scanned summary read K961104, FDA’s number for Notebook Imager (Digirad Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ethicon Ultracision ultrasonic hand instruments”. Kept off the family tree. Summary page 1…T 06856 Victor Clavelli May 19, 1997 Ultrasonic Surgical Instrument Ultrasonic hand instruments Not yet determined Ethicon Ultracision ultrasonic hand instruments, K961104 The subject instruments consists of three endoscopic hand instruments which connected by an acoustic transducer to a generator.… | 1997 |
What descends from it? (269)
See all 2693 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K980099 (Ethicon Endo-Surgery, Inc., 1998) has gone furthest, with 268 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 AUTO SUTURE® ultrasonic hand instruments have application in abdominal, pediatric,
gynecologic, thoracic, urologic and general open and endoscopic procedures for the
transection, dissection and coagulation of tissue(s). The instrument is available with a hook
probe, with a shear and with a ball probe.
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/K971861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971861: Ultrasonic Hand Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971861
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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