510(k) · Cleared
Recalled · Class I · 2013Lumenis Versacut Tissue Morcellator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 31, 2005 as substantially equivalent to K980079 (Lumenis, Inc., 1998) after a 17-day review. Its family tree reaches back 2 generations to 1991. 1 of the 12 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 31, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910939 (1991). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK910939 Cook Tissue MorcellatorCook Urological, Inc. · 1991
- 1 generation backK980079 Coherent Tissue Morcellator Kit and AccessoriesLumenis, Inc. · 1998
- This deviceK050639 Lumenis Versacut Tissue Morcellator SystemLumenis, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK133272 Versacut + Tissue MorcellatorLumenis, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · 2 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
- Descendant · 3 generations on · 0 of its ownK251923 Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133272Versacut + Tissue MorcellatorLumenis, Ltd. · 2014 · cites it directly5descendants
- K192499Cyber BladeSIDAM S.r.l. · 2020 · 2 generations on2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 2 generations on1descendant
- K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 3 generations on0descendants
- K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910939 | Cook Tissue Morcellator | Cook Urological, Inc. | 1991 | — |
| −1 | K980079 | Coherent Tissue Morcellator Kit and Accessories | Lumenis, Inc. | 1998 | — |
| 0 (this device) | K050639 | Lumenis Versacut Tissue Morcellator System | Lumenis, Inc. | 2005 | — |
| +1 | K133272 | Versacut + Tissue Morcellator | Lumenis, Ltd. | 2014 | 1 |
| +2 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +2 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
| +3 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
| +3 | K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K980079 | Coherent Tissue Morcellator Kit and AccessoriesSummary page 1…e: Electrosurgical Cutting and Coagulation Device and Accessories Device Classification: Class II Predicate Devices: Coherent Tissue Morcellator Kit (K980079, concurred April 9, 1998) Device Description: The VersaCutTm Tissue Morcellator System is a multiple-use elec… | 1998 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2013 | Class I | Z-0795-2013 | Labeling design | Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K133272 (Lumenis, Ltd., 2014) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Lumenis VersaCut Tm Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050639: Lumenis Versacut Tissue Morcellator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050639
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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