510(k) · Cleared
ClearedSurgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgrx, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 3, 2003 as substantially equivalent to K981916 (Valleylab, Inc., 1998) after an 85-day review. Its family tree reaches back 2 generations to 1994. 56 later devices descend from it.
- Decided
- Jul 3, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932293 (1994). 7 ancestors in all. 56 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 1 generation backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- This deviceK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- Descendant · cites it directly · 53 of its ownK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- Descendant · 2 generations on · 34 of its ownK063097 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- Descendant · 2 generations on · 32 of its ownK070896 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 26 of its ownK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- Descendant · cites it directly · 26 of its ownK050671 Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc. · 2005
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K061526Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006 · cites it directly53descendants
- K063097Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006 · 2 generations on34descendants
- K070896Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007 · 2 generations on32descendants
- K062949Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006 · 2 generations on26descendants
- K050671Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc. · 2005 · cites it directly26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| 0 (this device) | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| +1 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| +2 | K063097 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| +2 | K070896 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2007 | 1 |
| +2 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| +1 | K050671 | Enseal Vessel Sealing & Hemostasis System | Surgrx, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (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 | Decided |
|---|---|---|---|
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…section 878.4400) and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120). 3. Predicate Device Valleyl-ab LigaSure Vessel Sealing System (K981916). 4. Device Description The EnSeal Laparoscopic devices are tubular instruments with grasping jaws at the distal… | 1998 |
What descends from it? (56)
See all 566 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061526 | Enseal PTC Tissue Sealing Device | 2006 | 53 |
| K050671 | Enseal Vessel Sealing & Hemostasis System | 2005 | 26 |
| K043008 | Surgrx Enseal Vessel Sealing & Hemostasis System | 2004 | 25 |
| K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | 2008 | 24 |
| K071728 | Modification to: Enseal PTC Tissue Sealing Device | 2007 | 16 |
| K111202 | Surgical Tissue Management System | 2012 | 11 |
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 9 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K061526 (Surgrx, Inc., 2006) has gone furthest, with 53 descendants of its own.
- 15 other devices also cite its predicate K981916.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It Is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive…
Read the full statement (144 words)
The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It Is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the Instruments.
The SurgRx EnSeal Vessel Sealing & Hemoslasis System has not been shown effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031133: Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031133
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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