510(k) · Cleared
ClearedUnify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 11, 2022 as substantially equivalent to K172671 (Conmed Corporation, 2017) and 2 other predicates after a 150-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Mar 11, 2022
- Review
- 150 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K911904 (1991). 51 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 7 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 6 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 5 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 4 generations backK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- 3 generations backK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- 2 generations backK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
- 1 generation backK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- This deviceK213354 Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify…Conmed Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −7 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −6 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −5 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −4 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| −3 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| −2 | K151649 | Valleylab FT10 Electrosurgical Platform | Covidien | 2015 | — |
| −1 | K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| 0 (this device) | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar… | Conmed Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile PedestalSummary page 5…Primary Device Name: HelixAR ABC System Company Name: ConMed Corporation 510(k): K172671 Secondary Device Name: Valleylab FT10 Electrosurgical Platform Company Name: Covidien LLC… | 2017 |
| * | K170170 | Valleylab FT10 Electrosurgical PlatformSummary page 5…K172671 Secondary Device Name: Valleylab FT10 Electrosurgical Platform Company Name: Covidien LLC 510(k): K170170 Reference Device Name: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Company Name:… | 2017 |
| * | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedSummary page 5…evice Name: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Company Name: Covidien LLC 510(k): K170869 E. Device Description The Unify Multifunction Energy Platform (Unify MEP) is composed of an electrosurgical generator… | 2017 |
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 31 years and passes through 8 companies; a new generation was cleared every 5.1 years on median.
- 9 of the 51 ancestors have a recall of any class.
- 1 other device also cites its predicate K172671.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 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?
Unify Multifunction Energy Platform and Unify Cart The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired. This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. This generator, when used with compatible vessel sealing devices, is indicated for the ligation and division of tissue bundles…
Read the full statement (316 words)
Unify Multifunction Energy Platform and Unify Cart
The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired.
This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium.
This generator, when used with compatible vessel sealing devices, is indicated for the ligation and division of tissue bundles, lymphatics, and vessels in open and laparoscopic procedures. Reference instructions for use (IFU) for applicable vessel sealing devices.
The vessel sealing function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
CleanSeal Vessel Sealers
CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 7 mm vessels (arteries and veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic and vascular. These procedures include, but are not limited to, hysterectomies, oophorectomies, colectomies, Nissen fundoplication, and adhesiolysis. The CleanSeal Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CleanSeal Vessel Sealer for these procedures.
Unify Bipolar Resection Cables
The CONMED UNIFY Bipolar Resection Cables are used to connect compatible accessories to the CONMED UNIFY ESU. UNIFY Bipolar Resection Cables are used in conjunction with the Bipolar Resection capabilities of the UNIFY ESU for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. The CONMED UNIFY Bipolar Resection Cables are intended for use with only compatible resectoscopes (refer to Compatibility for details). Maximum rated voltage 750 V.
Unify Wireless FootSwitch
The Wireless Footswitch Kit is intended for use with the CONMED UNIFY™ Advanced Energy Generator for the operation of foot-controlled RF devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213354: Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213354
Report an extraction error
Are you the manufacturer?
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