510(k) · Cleared
ClearedFlex-THOR scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 18, 2019 as substantially equivalent to K100533 (Vibrynt, Inc., 2011) after a 56-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jan 18, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923982 (1993). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 3 generations backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- 2 generations backK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- 1 generation backK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
- This deviceK183264 Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −3 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| −2 | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| −1 | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
| 0 (this device) | 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 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models…Summary page 4…: Recognized Not Applicable for GCJ product code Consensus Standards: Predicate and Primary Predicate Device: Vibrynt Inc’s VISTA Endoscope Reference (K100533) Device(s): Reference Device: XLTF-VAW Laparo-Thoraco Videoscope (K053382) **The above… | 2011 |
| † | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | 2006 |
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 26 years and passes through 5 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 13 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Flex-THOR System is indicated 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/K183264 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183264: Flex-THOR scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183264
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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