510(k) · Cleared
ClearedMultiCut Solo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion Laser Technologies GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 18, 2023 as substantially equivalent to K133272 (Lumenis, Ltd., 2014) and 1 other predicate after a 432-day review. Its family tree reaches back 5 generations to 1987. 1 of the 19 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 18, 2023
- Review
- 432 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871250 (1987). 17 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 4 generations backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- 3 generations backK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- 2 generations backK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- 1 generation backK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- This deviceK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
- Descendant · cites it directly · 0 of its ownK240831 MultiCut SoloAsclepion Laser Technologies GmbH · 2024
Class I recalls in this family
- K050639 Lumenis Versacut Tissue Morcellator System2 generations back · 2005
Most influential descendants
Showing 1 of 1 · See all- K240831MultiCut SoloAsclepion Laser Technologies GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −4 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| −3 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| −2 | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| −1 | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| 0 (this device) | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
| +1 | K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K133272 | Versacut + Tissue MorcellatorSummary page 4…876.1500 Product Code: GCJ Basis for Submission: new submission Predicate Devices: VersaCut + Morcellator (K133272) MORCE SCOPE SET 8970 (K041610) Performance Standards: There are no mandatory performance… | 2014 |
| * | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Summary page 4…ssion: new submission Predicate Devices: VersaCut + Morcellator (K133272) MORCE SCOPE SET 8970 (K041610) Performance Standards: There are no mandatory performance standards for this device.… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240831 | MultiCut Solo | 2024 | 0 |
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 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240831 (Asclepion Laser Technologies GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133272.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213597: MultiCut Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213597
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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