510(k) · Cleared
ClearedHX Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Human Extension, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 20, 2018 as substantially equivalent to K061425 (Cambridge Endoscopic Devices, 2006) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1991. 8 later devices descend from it.
- Decided
- Mar 20, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912544 (1991). 15 ancestors in all, the oldest K910831 (1991). 8 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 3 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- 1 generation backK123102 Sovereign MiniAesculap, Inc. · 2013
- This deviceK173919 HX DeviceHuman Extension, Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260183 MediBot Needle Driver UnoParallel Robotics, LLC · 2026
- Descendant · cites it directly · 0 of its ownK243968 Revolve Surgical SystemRevolve Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK244029 Robopera (ER-R-002); Robopera (ER-R-003)Endorobotics Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223718 HandX™ Self-Righting Needle HolderHuman Xtensions, Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · cites it directly3descendants
- K260183MediBot Needle Driver UnoParallel Robotics, LLC · 2026 · cites it directly0descendants
- K243968Revolve Surgical SystemRevolve Surgical, Inc. · 2025 · cites it directly0descendants
- K244029Robopera (ER-R-002); Robopera (ER-R-003)Endorobotics Co., Ltd. · 2025 · cites it directly0descendants
- K223718HandX™ Self-Righting Needle HolderHuman Xtensions, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −3 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| −1 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| 0 (this device) | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| +1 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
| +1 | K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026 | — |
| +1 | K243968 | Revolve Surgical System | Revolve Surgical, Inc. | 2025 | — |
| +1 | K244029 | Robopera (ER-R-002); Robopera (ER-R-003) | Endorobotics Co., Ltd. | 2025 | — |
| +1 | K223718 | HandX™ Self-Righting Needle Holder | Human Xtensions, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K061425 | Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook…Summary page 4…ensions Ltd. believes that the HX Device is substantially equivalent to the following predicate devices: • Cambridge Endoscopic Devices Inc. PureWrist™ cleated under K061425 • Aesculap's Sovereign® mini system cleared under K123102 In addition, additional device the daVinci Surgical System (Intuit… | 2006 |
| * | K123102 | Sovereign MiniSummary page 4…valent to the following predicate devices: • Cambridge Endoscopic Devices Inc. PureWrist™ cleated under K061425 • Aesculap's Sovereign® mini system cleared under K123102 In addition, additional device the daVinci Surgical System (Intuitive Surgical Inc.) cleared under several clearances K131861 (p… | 2013 |
| † | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | 2014 |
| † | K170875 | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments… | 2017 |
What descends from it? (8)
6 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 27 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K203603 (Human Xtensions, Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K061425.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173919: HX Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173919
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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