510(k) · Cleared
ClearedSurgisure Tissue Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interlace Medical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 2, 2011 as substantially equivalent to K091100 (Interlace Medical, Inc., 2009) and 2 other predicates after a 69-day review. Its family tree reaches back 6 generations to 1995. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 2, 2011
- Review
- 69 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K953695 (1995). 14 ancestors in all, the oldest K910939 (1991). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 5 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 3 generations backK073690 Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc. · 2008
- 2 generations backK091100 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
- 1 generation backK100559 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
- This deviceK103741 Surgisure Tissue Removal SystemInterlace Medical, Inc. · 2011
Class I recalls in this family
- K050639 Lumenis Versacut Tissue Morcellator Systemdirect predicate · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −5 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −4 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −3 | K073690 | Interlace Medical Hysteroscopic Morcellation System | Interlace Medical, Inc. | 2008 | — |
| −2 | K091100 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2009 | — |
| −1 | K100559 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2010 | — |
| 0 (this device) | K103741 | Surgisure Tissue Removal System | Interlace Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 1 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K091100 | Myosure Hysteroscopic Tissue Removal SystemSummary page 1…essories Classification Name: Endoscope and accessories Class: 11 3. Predicate Device: MyoSure Tm Hysteroscopic Tissue Removal System (K091 100 & K100559). VersaCutTM Tissue Morcellator System (K050639) 4. Device Description: The SurgiSureTm Hyste… | 2009 |
| * | K100559 | Myosure Hysteroscopic Tissue Removal SystemSummary page 1…Classification Name: Endoscope and accessories Class: 11 3. Predicate Device: MyoSure Tm Hysteroscopic Tissue Removal System (K091 100 & K100559). VersaCutTM Tissue Morcellator System (K050639) 4. Device Description: The SurgiSureTm Hysteroscopic T… | 2010 |
| * | K050639 | Lumenis Versacut Tissue Morcellator SystemSummary page 1…Class: 11 3. Predicate Device: MyoSure Tm Hysteroscopic Tissue Removal System (K091 100 & K100559). VersaCutTM Tissue Morcellator System (K050639) 4. Device Description: The SurgiSureTm Hysteroscopic Tissue Removal System consists of the following p… | 2005 |
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 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K091100.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SurgiSure Tissue Removal 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/K103741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103741: Surgisure Tissue Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103741
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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