510(k) Report

510(k) · Cleared

Cleared

Multifunction Endoscopic Instrument

K012033510(k) TraditionalCleared Sep 20, 200183-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

Seedling Enterprises., LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 20, 2001 as substantially equivalent to K000496 (Everest Medical Corp., 2000) and 4 other predicates after an 83-day review. Its family tree reaches back 3 generations to 1991.

Decided
Sep 20, 2001
Review
83 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K912544 (1991). 7 ancestors in all, the oldest K884306 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1989: 1 other ancestorK912544 · Bipolar Forceps · Everest Medical Corp. · 1991K972415 · Minisite*Bipolar Forceps** Device · United States Surgical, A Division of Tyco Healthc · 1997K992760 · Select-Sutter Micro Bipolar Forceps · Select Medizintechnik Hermann Sutter GmbH · 19991985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K992760 · Select-Sutter Micro Bipolar Forceps · Select Medizintechnik Hermann Sutter GmbH · 1999K972415 · Minisite*Bipolar Forceps** Device · United States Surgical, A Division of Tyco Healthc · 1997K912544 · Bipolar Forceps · Everest Medical Corp. · 19910
  1. Root · 3 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
  2. 2 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
  3. 1 generation backK992760 Select-Sutter Micro Bipolar ForcepsSelect Medizintechnik Hermann Sutter GmbH · 1999
  4. This deviceK012033 Multifunction Endoscopic InstrumentSeedling Enterprises., LLC · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K912544Bipolar ForcepsEverest Medical Corp.1991—
−2K972415Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc1997—
−1K992760Select-Sutter Micro Bipolar ForcepsSelect Medizintechnik Hermann Sutter GmbH1999—
0 (this device)K012033Multifunction Endoscopic InstrumentSeedling Enterprises., LLC2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
200020
200110
FIG. 1 — Lineage of K012033, 1991–2001Source: 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
Get a 510(k) Report

What was it cleared against? (5)

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
*K000496Evershears Bipolar Scissors
Summary page 1
…Multifunction Endoscopic Instrument is substantially equivalent in intended use and/or function to the following predicate devices: Everest Evershears Bipolar Scissors K 000496, manufactured by Everest Medical Circon Tripolar Forceps 510(k) number unknown, believed to be legally marketed under K884306, m…
Everest Medical Corp.2000—
*K884306Bicap Ablating Forceps Baf-7
Summary page 1
…ces: Everest Evershears Bipolar Scissors K 000496, manufactured by Everest Medical Circon Tripolar Forceps 510(k) number unknown, believed to be legally marketed under K884306, manufactured by Circon Corporation Clearglide Bipolar Device K 003587, manufactured by Ethicon, Inc. Bipolar Trigger Flex Electr…
Circon Acmi1989—
*K003587Clearglide Precision Bipolar Device
Summary page 1
…erest Medical Circon Tripolar Forceps 510(k) number unknown, believed to be legally marketed under K884306, manufactured by Circon Corporation Clearglide Bipolar Device K 003587, manufactured by Ethicon, Inc. Bipolar Trigger Flex Electrode K003126, manufactured by eliman international inc Select-Sutter Mi…
ETHICON, Inc.200010
*K003126Bipolar Trigger-Flex Probe
Summary page 1
…to be legally marketed under K884306, manufactured by Circon Corporation Clearglide Bipolar Device K 003587, manufactured by Ethicon, Inc. Bipolar Trigger Flex Electrode K003126, manufactured by eliman international inc Select-Sutter Micro-Bipolar Forceps K992760, manufactured by Select Sutter GmbH 4. D…
Ellman Intl., Inc.2001—
*K992760Select-Sutter Micro Bipolar Forceps
Summary page 1
…olar Device K 003587, manufactured by Ethicon, Inc. Bipolar Trigger Flex Electrode K003126, manufactured by eliman international inc Select-Sutter Micro-Bipolar Forceps K992760, manufactured by Select Sutter GmbH 4. Device Description The Multifunction Endoscopic Instrument is a single patient use devi…
Select Medizintechnik Hermann Sutter GmbH1999—

Also cleared against K000496: 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)

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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K000496.

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 MEI is a laparoscopic and endoscopic, bipolar, electrosurgical device intended for grasping, dissecting, coagulating and transecting tissue in laparoscopic and open procedures.

The types of surgery indicated are:

General surgery

Laparoscopic procedures

Endoscopic procedures

Laryngeal coagulation

Orthopedic coagulation

Thorascopic coagulation

Neurosurgical coagulation

Gynecological coagulation, (except for use in female sterilization)

Ear, Nose and Throat coagulation

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 K000496

2 other devices cite the same predicate.

  • K024286Gyrus Open ForcepsGyrus Medical, Inc. · 20036 recalls
  • K020585Zip Open Forceps with Electrosurgical CutGyrus Medical, Inc. · 20021 recall

More from Seedling Enterprises., LLC

4 FDA decisions under this applicant name. See the company

  • K010710Seedling Enterprises LLC, Cool Tec Monopolar and Bipolar Reusable ElectrodesSeedling Enterprises., LLC · 2001
  • K002841Cool-Tec ElectrodesSeedling Enterprises., LLC · 2000
  • K001723Cool-Tec ElectrodesSeedling Enterprises., LLC · 2000

Recent decisions in GEI

The GEI category page

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  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K012033 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012033: Multifunction Endoscopic Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012033

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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