510(k) · Cleared

Recalled · Class II · 2017

Stretta Catheter

K152317510(k) SpecialCleared Sep 23, 201537-day reviewClass II21 CFR 878.4400Recalls 1

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

Mederi Therapeutics, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 23, 2015 as substantially equivalent to K000245 (Conway Stuart Medical, Inc., 2000) after a 37-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.

Decided: Sep 23, 2015
Review: 37 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K000245 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK000245 CSM Stretta SystemConway Stuart Medical, Inc. · 2000
This deviceK152317 Stretta CatheterMederi Therapeutics, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000245	CSM Stretta System	Conway Stuart Medical, Inc.	2000	—
0 (this device)	K152317	Stretta Catheter	Mederi Therapeutics, Inc.	2015	—

FIG. 1 — Lineage of K152317, 2000–2015Source: 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
*	K000245	CSM Stretta System Summary page 4 …oagulation device and accessories Regulation Number: 21 CFR 878.4400 Class 2 Product Code GEI Predicate Device K000245 - Conway Stuart Stretta System Catheter Intended Use Intended for general use in the electrosurgical coa…	Conway Stuart Medical, Inc.	2000	—

Also cleared against K000245: 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 3, 2017	Class II	Z-2050-2017	Package design/selection	Product sterility compromised due to breach in sterile barrier package

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K000245.

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. 2015, this device’s year, is highlighted.

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?

Intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of Gastroesophageal Reflux Disease (GERD)

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/K152317 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152317: Stretta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152317

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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