510(k) · Cleared
ClearedPK Zip Wing Cutting Dissector
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 Nov 13, 2002 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 26-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Nov 13, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904993 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- This deviceK023493 PK Zip Wing Cutting DissectorGyrus Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK163373 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK170908 PK AIMGyrus Acmi, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See allView 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) | K023493 | PK Zip Wing Cutting Dissector | Gyrus Medical, Inc. | 2002 | — |
| +1 | K081766 | PKS Omni Instrument | Gyrus-Acmi L.P. | 2008 | 1 |
| +2 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +3 | K163373 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +4 | K170908 | PK AIM | Gyrus Acmi, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K904993 | Laparoscopic Electrosurgical DeviceSummary page 1…ZIP WING Cutting Dissector The device is a Class I1 medical device. The PK ZIP WING Cutting Dissecting forceps is a modification to the predicate devices cleared under K904993. The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when… | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081766 | PKS Omni Instrument | 2008 | 3 |
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?
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?
Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue
during the performance of laparoscopic and general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023493: PK Zip Wing Cutting Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023493
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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