510(k) · Cleared
ClearedVista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models FG0027, FG0031, FG0029, FG 0028,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vibrynt, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 8, 2011 as substantially equivalent to K053382 (Olympus Medical Systems Corporation, 2006) and 2 other predicates after a 348-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Feb 8, 2011
- Review
- 348 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K923982 (1993). 12 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 backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- 1 generation backK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- This deviceK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK183264 Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183264Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. · 2019 · 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 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| −1 | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| 0 (this device) | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
| +1 | K183264 | Flex-THOR scope | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 |
|---|---|---|---|
| * | K053382 | Laparo-Thoraco Videoscope XLTF-VawSummary page 1…11 Codes and Endoscope and accessories (21 CFR 876.1500) Classification Names: Predicate Devices: Olympus Laparo-Thoraco Videoscope (K053382) Hans Hermann Laparoscopes and Accessories (K05161 0) Acclarent MicroEndo… | 2006 |
| * | K051610 | Hans Hermann Laparoscopes and AccessoriesSummary page 1…Classification Names: Predicate Devices: Olympus Laparo-Thoraco Videoscope (K053382) Hans Hermann Laparoscopes and Accessories (K05161 0) Acclarent MicroEndoscope (K063078) Device Description: The VISTA Endoscope is a flexible fib… | 2005 |
| * | K063078 | MicroendoscopeSummary page 1…aparo-Thoraco Videoscope (K053382) Hans Hermann Laparoscopes and Accessories (K05161 0) Acclarent MicroEndoscope (K063078) Device Description: The VISTA Endoscope is a flexible fiberscope that allows for visualizati… | 2006 |
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 |
|---|---|---|---|
| K183264 | Flex-THOR scope | 2019 | 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 18 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K183264 (KARL STORZ Endoscopy-America, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053382.
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 VISTA Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100533 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100533: Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models FG0027, FG0031, FG0029, FG 0028,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100533
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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