510(k) · Cleared

Cleared

CSM Stretta System

K000245510(k) TraditionalCleared Apr 18, 200082-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

Conway Stuart Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 18, 2000 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Apr 18, 2000
Review: 82 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

7 later devices descend from it, 3 citing it directly.

This deviceK000245 CSM Stretta SystemConway Stuart Medical, Inc. · 2000
Descendant · cites it directly · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
Descendant · 4 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
Descendant · 5 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002high 2 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · See all

K014216Secca SystemCuron Medical, Inc. · 2002 · cites it directly5descendants
K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 2 generations on3descendants
K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 3 generations on2descendants
K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 4 generations on1descendant
K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000245	CSM Stretta System	Conway Stuart Medical, Inc.	2000	—
+1	K014216	Secca System	Curon Medical, Inc.	2002	—
+2	K110143	Het Bipolar Electrocautery Forceps	Het Systems, LLC	2011	—
+3	K121085	Het Bipolar Ligator System	Het Systems, LLC	2012	—
+4	K140422	Het Systems, LLC, Het Bipolar Ligator System	Het Systems, LLC	2014	—
+5	K200146	HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor	Covidien, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2011	2	0
2012	1	0
2014	1	0
2015	1	0
2020	1	0

FIG. 1 — Lineage of K000245, 2000–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K014216	Secca System	Curon Medical, Inc.	2002	5
K152317	Stretta Catheter	Mederi Therapeutics, Inc.	2015	0
K103017	Mederi Therapeutics RF Generator Control Module	Mederi Therapeutics, Inc.	2011	0

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, K014216 (Curon Medical, Inc., 2002) has gone furthest, with 5 descendants of its own.

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	—

https://510kreport.com/device/K000245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000245: CSM Stretta System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000245

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026