510(k) · Cleared
ClearedModification to: Enseal PTC Tissue Sealing Device
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 13, 2007 as substantially equivalent to K031133 (Surgrx, Inc., 2003) and 2 other predicates after an 18-day review. Its family tree reaches back 4 generations to 1994. 16 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932293 (1994). 12 ancestors in all, the oldest K933002 (1994). 16 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 2 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 1 generation backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- This deviceK071728 Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007
- Descendant · cites it directly · 15 of its ownK110639 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2011 · Recalled
- Descendant · cites it directly · 10 of its ownK130266 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 9 of its ownK140189 Endowrist Vessel SealerIntuitive Surgical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 8 of its ownK170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci…Intuitive Surgical, Inc. · 2017
- Descendant · 4 generations on · 7 of its ownK173337 Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K110639Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2011 · cites it directly15descendants
- K130266Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2013 · cites it directly10descendants
- K140189Endowrist Vessel SealerIntuitive Surgical, Inc. · 2014 · 2 generations on9descendants
- K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc. · 2017 · 3 generations on8descendants
- K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −3 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −2 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −1 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| 0 (this device) | K071728 | Modification to: Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2007 | — |
| +1 | K110639 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2011 | 2 |
| +1 | K130266 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2013 | 1 |
| +2 | K140189 | Endowrist Vessel Sealer | Intuitive Surgical, Inc. | 2014 | 1 |
| +3 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site… | Intuitive Surgical, Inc. | 2017 | — |
| +4 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller…Summary page 1…tion 878.4400) and Gynecologic Electrocautery and Accessories (per 21 CIFR 884.4120). 3. Predicate Device EnSealTM Vessel Sealing and Hemostasis System # K031133, and the ERBE VIO ESUI, Model VIO 3000D, # K060484 and EnSeal PTC #tK061526. 4. Device Description EnSealTM PTC w… | 2003 |
| * | K060484 | Erbe Vio Esu, Model Vio 300 DSummary page 1…es (per 21 CIFR 884.4120). 3. Predicate Device EnSealTM Vessel Sealing and Hemostasis System # K031133, and the ERBE VIO ESUI, Model VIO 3000D, # K060484 and EnSeal PTC #tK061526. 4. Device Description EnSealTM PTC with ERBE VIO 300 D.The functionality of the device is the s… | 2006 |
| * | K061526 | Enseal PTC Tissue Sealing DeviceSummary page 1…84.4120). 3. Predicate Device EnSealTM Vessel Sealing and Hemostasis System # K031133, and the ERBE VIO ESUI, Model VIO 3000D, # K060484 and EnSeal PTC #tK061526. 4. Device Description EnSealTM PTC with ERBE VIO 300 D.The functionality of the device is the same as the predic… | 2006 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K110639 (Intuitive Surgical, Inc., 2011) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K031133.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The EnSeal PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. 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…
Read the full statement (142 words)
The EnSeal PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. 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 & Hemostasis System has not been shown to be 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/K071728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071728: Modification to: Enseal PTC Tissue Sealing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071728
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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