510(k) · Cleared
ClearedLaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Principals, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 1, 2023 as substantially equivalent to K081647 (Xodus Medical, Inc., 2008) and 1 other predicate after a 270-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Dec 1, 2023
- Review
- 270 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K932832 (1994). 22 ancestors in all, the oldest K913281 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
- 5 generations backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
- 4 generations backK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
- 3 generations backK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
- 2 generations backK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- 1 generation backK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- This deviceK230621 LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932832 | Primus Insulated Forceps | Marlo Surgical Technology | 1994 | — |
| −5 | K021237 | Coopersurgical Laparoscopic Instruments | CooperSurgical, Inc. | 2003 | — |
| −4 | K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | 2005 | — |
| −3 | K052759 | Dan Monopolar Lap Accessories | Dannoritzer Medizintechnik GmbH & Co. KG | 2006 | 1 |
| −2 | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| −1 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K230621 | LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K081647 | Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsSummary page 4…e LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes claim Substantial Equivalence to Xodus Medical, Inc. PTFE Coated Electrode Tips cleared under 510(k) K081647. Additionally, these devices claim the Unimax Medical Systems Laparoscopic Instruments cleared under 510(k) K103508 as a Seco… | 2008 |
| * | K103508 | Unmiax Laparoscopic InstrumentSummary page 4…. PTFE Coated Electrode Tips cleared under 510(k) K081647. Additionally, these devices claim the Unimax Medical Systems Laparoscopic Instruments cleared under 510(k) K103508 as a Secondary Predicate or Reference Device, specifically related to the Indication for Use. 4. DEVICE DESCRIPTION The Lapr… | 2011 |
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 29 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 22 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are intended to be used in general laparoscopic surgical procedures requiring the use of Monpolar electrosurgical cutting and/or coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230621: LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230621
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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