510(k) · Cleared

Cleared

Helica TC Laparoscopic Cutting and Cauterising (LTC) Probe

K032969510(k) TraditionalCleared Feb 4, 2004134-day reviewClass II21 CFR 878.4400

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

Helica Instruments, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 4, 2004 as substantially equivalent to K972267 (Tenerco, Inc., 1999) after a 134-day review. Its family tree reaches back 1 generation to 1999. 15 later devices descend from it.

Decided: Feb 4, 2004
Review: 134 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972267 (1999). 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK972267 Helica TCTenerco, Inc. · 1999
This deviceK032969 Helica TC Laparoscopic Cutting and Cauterising (LTC) ProbeHelica Instruments, Ltd. · 2004
Descendant · cites it directly · 14 of its ownK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
Descendant · 2 generations on · 8 of its ownK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
Descendant · 2 generations on · 5 of its ownK073313 Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008
Descendant · 3 generations on · 4 of its ownK093451 Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low…Omniguide, Inc. · 2009
Descendant · 3 generations on · 2 of its ownK140378 Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005high 3 (2006) · low 0 (2010)2026

Most influential descendants

Showing 5 of 15 · See all

K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005 · cites it directly14descendants
K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · 2 generations on8descendants
K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008 · 2 generations on5descendants
K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc. · 2009 · 3 generations on4descendants
K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972267	Helica TC	Tenerco, Inc.	1999	—
0 (this device)	K032969	Helica TC Laparoscopic Cutting and Cauterising (LTC) Probe	Helica Instruments, Ltd.	2004	—
+1	K050541	Omniguide Beampath CO2 Mark I Laser Beam Delivery	Omniguide Communications, Inc.	2005	—
+2	K070157	Omniguide Beam Path CO2 Mark Iii Waveguide Fiber	Omniguide, Inc.	2007	1
+2	K073313	Mark Iii Waveguide Fiber with Low Profile Tip	Omniguide, Inc.	2008	—
+3	K093451	Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip	Omniguide, Inc.	2009	—
+3	K140378	Flexguide Ultra Beampath Robotic Fiber Conduit	Omniguide, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	3	0
2008	1	0
2009	1	0
2011	1	0
2014	1	0
2017	1	0
2021	3	0

FIG. 1 — Lineage of K032969, 1999–2021Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K972267	Helica TC Summary page 1 …obe Commnii Name: Helitum Cutting Probe Classification: Class II Legally Marketed Predicate ]Device Name: 1-elica "TC,' Laparoscopic Cauterising (L-T) Probe, K972267 Description of Device: "The device is a helium gas electrosurgical coagulator for use in all soft fissue surgery-laparoscopic.…	Tenerco, Inc.	1999	—

Also cleared against K972267: 1 other device →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050541	Omniguide Beampath CO2 Mark I Laser Beam Delivery	Omniguide Communications, Inc.	2005	14

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?

Its one ancestor has no recall.
Of its descendants, K050541 (Omniguide Communications, Inc., 2005) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate K972267.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The device is a helium gas electro surgical cutting and coagulator for use in all soft tissue surgery- laparoscopic, endoscopic and open.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032969 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032969: Helica TC Laparoscopic Cutting and Cauterising (LTC) Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032969

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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