510(k) · Cleared

Cleared

Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 Blade

K971302510(k) TraditionalCleared Jul 7, 199790-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ethicon Endo-Surgery, Inc. · LFL Instrument, Ultrasonic Surgical

Cleared on Jul 7, 1997 after a 90-day review. The FDA summary names no predicate by number. 53 later devices descend from it.

Decided: Jul 7, 1997
Review: 90 days
Class: Class U
Product code: LFL
Recalls: None
Predicates: 0

53 later devices descend from it, 2 citing it directly.

This deviceK971302 Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 BladeEthicon Endo-Surgery, Inc. · 1997
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 · 5 generations on · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

1999high 7 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 53 · 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
K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · 5 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971302	Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 Blade	Ethicon Endo-Surgery, Inc.	1997	—
+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	—
+5	K092482	Tissu Trans Filtron, Models 3-TT-Filtron 2000-500	Shippert Medical Technologies Corp.	2009	8

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2004	2	0
2005	1	0
2007	3	0
2008	1	0
2009	2	0
2010	5	0
2011	1	0
2012	7	0
2013	1	0
2014	4	0
2015	3	0
2016	1	0
2017	5	0
2018	1	0
2019	4	0
2020	2	0
2021	2	0
2022	2	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K971302, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (53)

See all 53

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993868	The Soundvaser Dissection System	Sound Surgical Technologies, LLC	1999	49
K063531	Series 3 Lotus Laparoscopic Ultrasound Surgery System	Sra Developments, Ltd.	2007	2

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 devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFL

3in 2025

2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007high 241 (2011) · low 66 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFL

11in 2024

2007high 42 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFL

3,857in 2025

2007high 4,260 (2014) · low 1,053 (2011)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 LaparoSonic® Hook Blades and UltraCision HS2 Blade 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 and thoracic surgery, including the 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/K971302 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971302: Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971302

Report an extraction error

Are you the manufacturer?

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