510(k) Report

510(k) · Cleared

Cleared

Stretta Inflatable Basket Catheter Electrode with Aspiration

K991291510(k) TraditionalCleared Jul 14, 199990-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 Jul 14, 1999 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Jul 14, 1999
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK991291 Stretta Inflatable Basket Catheter Electrode with AspirationConway Stuart Medical, Inc. · 1999
  2. Descendant · cites it directly · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
  3. Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
  4. Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
  5. Descendant · 4 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
  6. Descendant · 5 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12011: 22012: 12014: 12020: 1
2002high 2 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991291Stretta Inflatable Basket Catheter Electrode with AspirationConway Stuart Medical, Inc.1999—
+1K014216Secca SystemCuron Medical, Inc.2002—
+2K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC2011—
+3K121085Het Bipolar Ligator SystemHet Systems, LLC2012—
+4K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC2014—
+5K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201120
201210
201410
202010
FIG. 1 — Lineage of K991291, 1999–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K014216Secca SystemCuron Medical, Inc.20025

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

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
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

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Indicated for coagulation of tissue

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Conway Stuart Medical, Inc.

10 FDA decisions under this applicant name. See the company

  • K000245CSM Stretta SystemConway Stuart Medical, Inc. · 2000
  • K000170Secca Tubular Electrode Device, Model A4000Conway Stuart Medical, Inc. · 2000
  • K992542Tubular Electrode DeviceConway Stuart Medical, Inc. · 1999
  • K991529CSM Stretta Control Module Electrosurgical Generator, Model S400Conway Stuart Medical, Inc. · 1999
  • K990724Conway Stuart Model 100 Irrigation Pump & AccessoriesConway Stuart Medical, Inc. · 1999

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https://510kreport.com/device/K991291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991291: Stretta Inflatable Basket Catheter Electrode with Aspiration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991291

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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