510(k) Report

510(k) · Cleared

Cleared

Secca System

K014216510(k) TraditionalCleared Mar 21, 200290-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

Curon Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 21, 2002 as substantially equivalent to K010210 (Curon Medical, Inc., 2001) and 9 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.

Decided
Mar 21, 2002
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
10

Its longest line of descent runs back 2 generations to K933157 (1994). 12 ancestors in all, the oldest K904646 (1991). 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1999: 2 other ancestors1998: 2 other ancestors1997: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor2011: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant clearedK933157 · Erbotom Icc 200 · Erbe USA, Inc. · 1994K992382 · Surgitron Radiolase · Ellman Intl., Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K992382 · Surgitron Radiolase · Ellman Intl., Inc. · 1999K933157 · Erbotom Icc 200 · Erbe USA, Inc. · 19940
  1. Root · 2 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
  2. 1 generation backK992382 Surgitron RadiolaseEllman Intl., Inc. · 1999
  3. This deviceK014216 Secca SystemCuron Medical, Inc. · 2002
  4. Descendant · cites it directly · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
  5. Descendant · 2 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
  6. Descendant · 3 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
  7. Descendant · 4 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
  8. Descendant · cites it directly · 0 of its ownK103017 Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc. · 2011

Most influential descendants

Showing 5 of 5 · See all
  • K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · cites it directly3descendants
  • K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 2 generations on2descendants
  • K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 3 generations on1descendant
  • K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020 · 4 generations on0descendants
  • K103017Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933157Erbotom Icc 200Erbe USA, Inc.1994—
−1K992382Surgitron RadiolaseEllman Intl., Inc.1999—
0 (this device)K014216Secca SystemCuron Medical, Inc.2002—
+1K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC2011—
+2K121085Het Bipolar Ligator SystemHet Systems, LLC2012—
+3K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC2014—
+4K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC2020—
+1K103017Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199710
199820
199920
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201410
202010
FIG. 1 — Lineage of K014216, 1994–2020Source: 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 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. #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
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What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010210Control Module Algorithm Enhancement for the Model S500-ST and Model S400
Summary page 2
…eral intended use of the Secca System to coagulate tissue electrosurgically is the same as the general intended use of Curon Medical’s previously cleared Stretta System (K010210 and K000245) (“Stretta”), Secca Tubular Electrode (K000170), A4000 Tubular Electrode (K992542), and Stretta Inflatable Basket Ele…
Curon Medical, Inc.2001—
*K000245CSM Stretta System
Summary page 1
…ctrosurgical accessories Classification Name Electrosurgical cuttingand coagulation device and accessories Predicate Devices Stretta System (K.010210 Stretta System (K000245) Stretta Inflatable Basket Electrode (K991291) Secca Tubular Electrode (K000170) SRCEN Kol4zie =/3 5. A4000 Tu…
Conway Stuart Medical, Inc.2000—
*K991291Stretta Inflatable Basket Catheter Electrode with Aspiration
Summary page 1
…lectrosurgical cuttingand coagulation device and accessories Predicate Devices Stretta System (K.010210 Stretta System (K000245) Stretta Inflatable Basket Electrode (K991291) Secca Tubular Electrode (K000170) SRCEN Kol4zie =/3 5. A4000 Tubular Electrode (K992542) 6. BioCare Internatio…
Conway Stuart Medical, Inc.1999—
*K000170Secca Tubular Electrode Device, Model A4000
Summary page 1
…ion device and accessories Predicate Devices Stretta System (K.010210 Stretta System (K000245) Stretta Inflatable Basket Electrode (K991291) Secca Tubular Electrode (K000170) SRCEN Kol4zie =/3 5. A4000 Tubular Electrode (K992542) 6. BioCare International's BCI-100 Fecal Incontinence S…
Conway Stuart Medical, Inc.2000—
*K992542Tubular Electrode Device
Summary page 2
…Stretta System (K000245) Stretta Inflatable Basket Electrode (K991291) Secca Tubular Electrode (K000170) SRCEN Kol4zie =/3 5. A4000 Tubular Electrode (K992542) 6. BioCare International's BCI-100 Fecal Incontinence System (K904646) 7. Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913…
Conway Stuart Medical, Inc.1999—
*K904646Bci-100 Fecal Incontinence System
Summary page 2
…Secca Tubular Electrode (K000170) SRCEN Kol4zie =/3 5. A4000 Tubular Electrode (K992542) 6. BioCare International's BCI-100 Fecal Incontinence System (K904646) 7. Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913736) 8. FEthicon’s PowerStar Bipolar Scissors (K981361) 9. Ellman’s Sur…
Biocare Intl.1991—
*K913736Dobbhoff Anorect Biofeed Syst Five Div Fecal Const
Summary page 2
…zie =/3 5. A4000 Tubular Electrode (K992542) 6. BioCare International's BCI-100 Fecal Incontinence System (K904646) 7. Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913736) 8. FEthicon’s PowerStar Bipolar Scissors (K981361) 9. Ellman’s Surgitron Radiolase System and Accessories (K992382) 10. Portlyn…
Biosearch Medical Products, Inc.1992—
*K981361Powerstar Bipolar Scissors
Summary page 2
…oCare International's BCI-100 Fecal Incontinence System (K904646) 7. Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913736) 8. FEthicon’s PowerStar Bipolar Scissors (K981361) 9. Ellman’s Surgitron Radiolase System and Accessories (K992382) 10. Portlyn Corporation's Dynabite Hot Gastroenterology Biopsy…
ETHICON, Inc.1998—
*K992382Surgitron Radiolase
Summary page 2
…7. Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913736) 8. FEthicon’s PowerStar Bipolar Scissors (K981361) 9. Ellman’s Surgitron Radiolase System and Accessories (K992382) 10. Portlyn Corporation's Dynabite Hot Gastroenterology Biopsy Forceps (K970083) Intended Use The Secca’™ System is intended fo…
Ellman Intl., Inc.1999—
*K970083Dynabite Hot GI Biopsy Forceps
Summary page 2
…rStar Bipolar Scissors (K981361) 9. Ellman’s Surgitron Radiolase System and Accessories (K992382) 10. Portlyn Corporation's Dynabite Hot Gastroenterology Biopsy Forceps (K970083) Intended Use The Secca’™ System is intended for general use in the electrosurgical coagulation of tissue and intended for use s…
Portlyn Corp.1997—

Also cleared against K010210: 1 other device →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC20113
K103017Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc.20110

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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K110143 (Het Systems, LLC, 2011) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K010210.

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?

The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K010210

1 other device cites the same predicate.

  • K103017Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc. · 2011

More from Curon Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K010210Control Module Algorithm Enhancement for the Model S500-ST and Model S400Curon Medical, Inc. · 2001
  • K002898Curon Control Module Electrosurgical Generator and Accessories, Model S500-STCuron Medical, Inc. · 2000

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https://510kreport.com/device/K014216 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014216: Secca System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014216

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026