510(k) · Cleared
ClearedLaparo-Thoraco Videoscope XLTF-Vaw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 26, 2006 as substantially equivalent to K955403 (Olympus America, Inc., 1996) and 1 other predicate after a 172-day review. Its family tree reaches back 2 generations to 1993. 8 later devices descend from it.
- Decided
- May 26, 2006
- Review
- 172 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923982 (1993). 6 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 1 generation backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- This deviceK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- Descendant · cites it directly · 4 of its ownK081173 Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008
- Descendant · 2 generations on · 3 of its ownK111648 Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · Recalled
- Descendant · cites it directly · 1 of its ownK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK201096 CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK190985 BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K081173Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008 · cites it directly4descendants
- K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · 2 generations on3descendants
- K100533Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models…Vibrynt, Inc. · 2011 · cites it directly1descendant
- K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020 · 3 generations on0descendants
- K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −1 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| +1 | K081173 | Endoscopic CO2 Regulation Unit Ucr | Olympus Medical Systems Corporation | 2008 | — |
| +2 | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | Bracco Diagnostic, Inc. | 2011 | 1 |
| +1 | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
| +3 | K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020 | — |
| +3 | K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K955403 | Oes Laparo-Thoraco Videoscope Type VSummary page 2…LTF-V LAPARO THORACO VIDEOSCOPE Common Name: LAPARO THORACO VIDEOSCOPE 510(k) No. K955403 Manufacturer: Olympus Optical Co., Ltd. (2) Device Name: A4907 LENS CLEAN… | 1996 |
| * | K011151 | Evis Exera Gastrointestinal Videoscope Gif-Q160ZSummary page 2…EVIS EXERA GASTROINTESTINAL VIDEOSCOPE Common Name: GASTROINTESTINAL VIDEOSCOPE 510(k) No. K011151 Manufacturer: Olympus Optical Co., Ltd. 4. Device Description The subject device, LAPARO-… | 2001 |
What descends from it? (8)
3 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 13 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K081173 (Olympus Medical Systems Corporation, 2008) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K955403.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053382 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053382: Laparo-Thoraco Videoscope XLTF-Vaw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053382
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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