510(k) · Cleared
ClearedHandX™ Self-Righting Needle Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Human Xtensions, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 5, 2023 as substantially equivalent to K173919 (Human Extension, Ltd., 2018) after a 175-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 5, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912544 (1991). 16 ancestors in all, the oldest K910831 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 4 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 3 generations backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- 2 generations backK123102 Sovereign MiniAesculap, Inc. · 2013
- 1 generation backK173919 HX DeviceHuman Extension, Ltd. · 2018
- This deviceK223718 HandX™ Self-Righting Needle HolderHuman Xtensions, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −4 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −3 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| −2 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| −1 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| 0 (this device) | 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 |
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? (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.
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 5 other devices also cite its predicate K173919.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 HandX is intended to assist in the control of Human Xtensions 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223718 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223718: HandX™ Self-Righting Needle Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223718
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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