510(k) · Cleared
Recalled · 2006Zip Open Forceps with Electrosurgical Cut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 13, 2002 as substantially equivalent to K000496 (Everest Medical Corp., 2000) and 1 other predicate after a 141-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Jul 13, 2002
- Review
- 141 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904993 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- This deviceK020585 Zip Open Forceps with Electrosurgical CutGyrus Medical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904993 | Laparoscopic Electrosurgical Device | Everest Medical Corp. | 1991 | — |
| 0 (this device) | K020585 | Zip Open Forceps with Electrosurgical Cut | Gyrus Medical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K000496 | Evershears Bipolar ScissorsSummary page 1…with Electrosurgical Cut The device is a Class II medical device. The Zip Open Forceps with Electrosurgical Cut is a modification to the predicate device cleared under K000496. The Open Forceps is similar in construction and in component materials when compared to the predicate device. The indications fo… | 2000 |
| * | K904993 | Laparoscopic Electrosurgical DeviceSummary page 1…in construction and in component materials when compared to the predicate device. The indications for use are similar to the predicate devices cleared under KO00496 and K904993. The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physicia… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2006 | Not classified | Z-1175-06 | Other | Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K000496.
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?
Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding
of tissue during open surgical procedures and in general surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020585: Zip Open Forceps with Electrosurgical Cut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020585
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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