510(k) · Cleared
ClearedTroCare TroKit Laparoscope Lens Wiper (CP000626)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TroCare, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 4, 2024 as substantially equivalent to K192891 (Medeon Biodesign, Inc., 2019) and 2 other predicates after a 105-day review. Its family tree reaches back 16 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 4, 2024
- Review
- 105 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K930667 (1994). 107 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 12 generations between
- 3 generations backK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
- 2 generations backK141272 Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield…Minimmally Invasive Devices · 2014
- 1 generation backK150705 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator…Minimally Invasive Devices, Inc. · 2015
- This deviceK241796 TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC · 2024
- Descendant · cites it directly · 0 of its ownK253994 TroKit Laparoscope Lens WiperTroCare, LLC · 2026
- Descendant · cites it directly · 0 of its ownK260089 TL-10 Laparoscopic Scope CleanerScopix, Ltd. · 2026
Show all 16 generations
- Root · 16 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 15 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 14 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 13 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 12 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 11 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 10 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 9 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 8 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 7 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 6 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 5 generations backK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
- 4 generations backK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
- 3 generations backK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
- 2 generations backK141272 Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield…Minimmally Invasive Devices · 2014
- 1 generation backK150705 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator…Minimally Invasive Devices, Inc. · 2015
- This deviceK241796 TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −15 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −14 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −13 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −12 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −11 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −10 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −9 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −8 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −7 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −6 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −5 | K112208 | Intutive Surgical DA Vinci Single Site Instruments and Accessories | Intuitive Surgical, Inc. | 2011 | 12 |
| −4 | K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper… | Intuitive Surgical, Inc. | 2012 | 3 |
| −3 | K122532 | DA Vinci Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | 2013 | 6 |
| −2 | K141272 | Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM… | Minimmally Invasive Devices | 2014 | — |
| −1 | K150705 | FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm… | Minimally Invasive Devices, Inc. | 2015 | — |
| 0 (this device) | K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | 2024 | — |
| +1 | K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026 | — |
| +1 | K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
Planning a device in GCJ? 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 |
|---|---|---|---|
| * | K192891 | Laparoscope Lens Shield Device (LENS)Summary page 6…76.1500) Name Regulatory Class: II Product Code: GCJ 510(K) Identification: K241796 III. PREDICATE DEVICE Medeon ClickClean, K192891 IV. DEVICE DESCRIPTION Design Characteristics The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable lapa… | 2019 |
| * | K150705 | FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Summary page 7…EVICE The TroKit Laparoscope Lens Wiper shares indications for use and design principles with the following predicate devices: Medeon ClickClean (K192891), FlowShield (K150705) and the ClearCam System (K200228); all Class II medical device that was cleared for marketing in the United States under K1928… | 2015 |
| * | K200228 | ClearCam SystemSummary page 7…Wiper shares indications for use and design principles with the following predicate devices: Medeon ClickClean (K192891), FlowShield (K150705) and the ClearCam System (K200228); all Class II medical device that was cleared for marketing in the United States under K192891, K150705, and K200228. Indic… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 22 of the 107 ancestors have a recall of any class.
- Of its descendants, K253994 (TroCare, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K192891.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Xi Surgical System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241796: TroCare TroKit Laparoscope Lens Wiper (CP000626).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241796
Report an extraction error
Are you the manufacturer?
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