510(k) · Cleared
ClearedVisionPort System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New View Surgical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 21, 2021 as substantially equivalent to K161838 (Xenocor, Inc., 2016) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Jun 21, 2021
- Review
- 56 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923982 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 2 generations backK150633 ULTRA TelescopesOlympus Winter & Ibe GmbH · 2015
- 1 generation backK161838 Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2016
- This deviceK211250 VisionPort SystemNew View Surgical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK241502 P-ScopeOui Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241502P-ScopeOui Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −2 | K150633 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2015 | — |
| −1 | K161838 | Xenocor Xenoscope Laparoscopic System | Xenocor, Inc. | 2016 | — |
| 0 (this device) | K211250 | VisionPort System | New View Surgical, Inc. | 2021 | — |
| +1 | K241502 | P-Scope | Oui Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K161838 | Xenocor Xenoscope Laparoscopic SystemSummary page 4…(and Accessories); 21 C.F.R. §884.1720 Regulatory Class: II Product Code(s): GCJ and HET PREDICATE DEVICE(S) Primary: Xenocor Xenoscope Laparoscopic System cleared in K161838 Secondary: ENDOPATH XCEL Bladeless Trocar cleared in K122511 DEVICE DESCRIPTION The VisionPort System consists of an access port… | 2016 |
| * | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar…Summary page 4…roduct Code(s): GCJ and HET PREDICATE DEVICE(S) Primary: Xenocor Xenoscope Laparoscopic System cleared in K161838 Secondary: ENDOPATH XCEL Bladeless Trocar cleared in K122511 DEVICE DESCRIPTION The VisionPort System consists of an access port with an integrated camera and light source, the handpiece, a… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241502 | P-Scope | 2024 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K241502 (Oui Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161838.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 VisionPort System is intended to be used in diagnostic and therapeutic procedures for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs to establish a path of entry for endoscopic instruments and to provide an image of the surgical field. The trocar may be used with or without visualization for primary and secondary insertions.
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/K211250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211250: VisionPort System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211250
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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