510(k) · Cleared

Cleared

Dissectron Portable Unit

K972612510(k) TraditionalCleared Oct 8, 199786-day reviewClass U

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

Satelec · LBK Neurosurgical Ultrasonic Instruments

Cleared on Oct 8, 1997 as substantially equivalent to K864983 (Cooper Lasersonics, Inc., 1987) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1986.

Decided: Oct 8, 1997
Review: 86 days
Class: Class U
Product code: LBK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K855138 (1986). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK855138 Bovie Ultrasonic Surgical SystemClinical Technology Corp. · 1986
This deviceK972612 Dissectron Portable UnitSatelec · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K855138	Bovie Ultrasonic Surgical System	Clinical Technology Corp.	1986	—
0 (this device)	K972612	Dissectron Portable Unit	Satelec	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1988	1	0

FIG. 1 — Lineage of K972612, 1986–1997Source: 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 LBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K864983	Cusa System 200 Macro-Dissector Our OCR of the scanned summary read K864943, FDA’s number for Numed Balloon Wedge Pressure Catheter (NuMED, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cooper Cavitron CUSA 200M”.	Cooper Lasersonics, Inc.	1987	—
*	K883091	Sharplan 4300 & 4310 Ultrasonic Surgical Apirators Summary page 1 …The DISSECTRON is substantially equivalent to the following previously cleared and currently marketing devices: Cooper Cavitron CUSA 200M (K864943) Sharplan 4300/4310 (K883091) Clinical Technology BOVIE (K855138A) D. Device Description The DISSECTRON is an ultrasonically vibrating hand-held surgical as…	Sharplan Lasers, Inc.	1988	—
*	K855138	Bovie Ultrasonic Surgical System Summary page 1 …valent to the following previously cleared and currently marketing devices: Cooper Cavitron CUSA 200M (K864943) Sharplan 4300/4310 (K883091) Clinical Technology BOVIE (K855138A) D. Device Description The DISSECTRON is an ultrasonically vibrating hand-held surgical aspirator designed to precisely fragme…	Clinical Technology Corp.	1986	—

Also cleared against K864983: 2 other devices →

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?

None of the 3 ancestors has a recall.
2 other devices also cite its predicate K864983.

How does its category compare?

All LBK devices

LBK Neurosurgical Ultrasonic Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBK

FDA has decided no LBK device since 2007.

Median 510(k) review, days · LBK

Too few LBK 510(k)s in any year since 2007 to give a median.

Recalls per year · LBK

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LBK

2in 2025

2007high 16 (2013) · low 0 (2009)2025

MAUDE reports naming product code LBK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	3
2008	—	0	1
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	4
2013	—	1	16
2014	—	0	9
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	4
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

Fragmentation, emulsification and aspiration of soft tissue in

the neurosurgery field.

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/K972612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972612: Dissectron Portable Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972612

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