510(k) · Cleared
ClearedCoherent Tissue Morcellator Kit and Accessories
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 Apr 9, 1998 as substantially equivalent to K925851 (Cook Urological, Inc., 1993) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1991. 1 of the 12 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Apr 9, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910939 (1991). 3 ancestors in all. 8 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK910939 Cook Tissue MorcellatorCook Urological, Inc. · 1991
- This deviceK980079 Coherent Tissue Morcellator Kit and AccessoriesLumenis, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK050639 Lumenis Versacut Tissue Morcellator SystemLumenis, Inc. · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK133272 Versacut + Tissue MorcellatorLumenis, Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · 3 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
- Descendant · 4 generations on · 0 of its ownK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K050639 Lumenis Versacut Tissue Morcellator Systemcites it directly · 2005
Most influential descendants
Showing 5 of 8 · See all- K050639Lumenis Versacut Tissue Morcellator SystemLumenis, Inc. · 2005 · cites it directly7descendants
- K133272Versacut + Tissue MorcellatorLumenis, Ltd. · 2014 · 2 generations on5descendants
- K192499Cyber BladeSIDAM S.r.l. · 2020 · 3 generations on2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 3 generations on1descendant
- K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910939 | Cook Tissue Morcellator | Cook Urological, Inc. | 1991 | — |
| 0 (this device) | K980079 | Coherent Tissue Morcellator Kit and Accessories | Lumenis, Inc. | 1998 | — |
| +1 | K050639 | Lumenis Versacut Tissue Morcellator System | Lumenis, Inc. | 2005 | Class I |
| +2 | K133272 | Versacut + Tissue Morcellator | Lumenis, Ltd. | 2014 | 1 |
| +3 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +3 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
| +4 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 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 |
|---|---|---|
| 2005 | 1 | 1 |
| 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? (3)
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 |
|---|---|---|---|
| * | K925851 | Cook Tissue MorcellatorSummary page 1…sification Name: Electrosurgical Cutting and Coagulation Device and Accessories . Predicate Devices * Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939) * Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604) Product Description The Coh… | 1993 |
| * | K910939 | Cook Tissue MorcellatorSummary page 1…ame: Electrosurgical Cutting and Coagulation Device and Accessories . Predicate Devices * Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939) * Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604) Product Description The Coherent Tissue… | 1991 |
| * | K935604 | Lasersonics Tissue Morcellator SetSummary page 1…s * Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939) * Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604) Product Description The Coherent Tissue Morcellator Kit is intended for use under direct or endoscopic visualization for the m… | 1994 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050639 | Lumenis Versacut Tissue Morcellator System Class I | 2005 | 7 |
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 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K050639 (Lumenis, Inc., 2005) has gone furthest, with 7 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 Coherent Tissue Morcellator Kit 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980079: Coherent Tissue Morcellator Kit and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980079
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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