510(k) · Cleared
ClearedUNIDRIVE Select System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 1, 2026 as substantially equivalent to K192499 (SIDAM S.r.l., 2020) after a 168-day review. Its family tree reaches back 6 generations to 1987. 1 of the 19 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 1, 2026
- Review
- 168 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K871250 (1987). 18 ancestors in all. No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 5 generations backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- 4 generations backK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- 3 generations backK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- 2 generations backK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- 1 generation backK192499 Cyber BladeSIDAM S.r.l. · 2020
- This deviceK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
Class I recalls in this family
- K050639 Lumenis Versacut Tissue Morcellator System3 generations back · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −5 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| −4 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| −3 | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| −2 | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| −1 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| 0 (this device) | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
| 2014 | 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.
1 device in this family has a Class I recall. 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 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 |
|---|---|---|---|
| * | K192499 | Cyber BladeSummary page 5…tion Number: 21 CFR 876.1500 Regulatory Class II Product Code: GCJ Classification Gastroenterology/Urology Panel: Predicate Predicate Device : Cyber Blade (K192499) Device(s): Reference Device: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2… | 2020 |
| † | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050639Lumenis Versacut Tissue Morcellator SystemLumenis, Inc. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K192499.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The UNIDRIVE Select System is intended for cutting and removal of enucleated prostrate tissue from the lower urinary tract in endoscopic interventions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260884: UNIDRIVE Select System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260884
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026