510(k) · Cleared
ClearedBariatric Laparoscope, Model 367
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 27, 1999 after a 47-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 12 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 47 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
12 later devices descend from it, 3 citing it directly.
- This deviceK993045 Bariatric Laparoscope, Model 367Stryker Endoscopy · 1999
- Descendant · cites it directly · 6 of its ownK161838 Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK193315 Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK220872 Saberscope5 LaparoscopeXenocor, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK201151 O-Mec 690 Series LaparoscopesOmec Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK211250 VisionPort SystemNew View Surgical, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K161838Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2016 · cites it directly6descendants
- K193315Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. · 2020 · 2 generations on3descendants
- K220872Saberscope5 LaparoscopeXenocor, Inc. · 2022 · 3 generations on2descendants
- K201151O-Mec 690 Series LaparoscopesOmec Medical, Inc. · 2020 · cites it directly2descendants
- K211250VisionPort SystemNew View Surgical, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993045 | Bariatric Laparoscope, Model 367 | Stryker Endoscopy | 1999 | — |
| +1 | K161838 | Xenocor Xenoscope Laparoscopic System | Xenocor, Inc. | 2016 | — |
| +2 | K193315 | Xenocor Articulating Xenoscope Laparoscope | Xenocor, Inc. | 2020 | — |
| +3 | K220872 | Saberscope5 Laparoscope | Xenocor, Inc. | 2022 | — |
| +1 | K201151 | O-Mec 690 Series Laparoscopes | Omec Medical, Inc. | 2020 | — |
| +2 | K211250 | VisionPort System | New View Surgical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K910132 | FDA’s K910132 is Stryker Laparoscope Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1991 |
What descends from it? (12)
See all 123 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?
- Of its descendants, K161838 (Xenocor, Inc., 2016) has gone furthest, with 6 descendants of its own.
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?
Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.
Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.
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/K993045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993045: Bariatric Laparoscope, Model 367.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993045
Report an extraction error
Are you the manufacturer?
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