510(k) · Cleared
ClearedLaparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Optomedic Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 6, 2023 as substantially equivalent to K223923 (KARL STORZ Endoscopy-America, Inc., 2023) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jul 6, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993045 (1999). 4 ancestors in all, the oldest K935279 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993045 | Bariatric Laparoscope, Model 367 | Stryker Endoscopy | 1999 | — |
| −1 | K201151 | O-Mec 690 Series Laparoscopes | Omec Medical, Inc. | 2020 | — |
| 0 (this device) | K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA… | Guangdong Optomedic Technologies, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K223923 | HOPKINS TelescopesSummary page 4…21 CFR 876.1500 Regulatory Class: Class II Product Code: GCJ III. Predicate Device Primary Predicate Device 510(k) Number: K223923 Product Name: HOPKINS Telescopes Secondary Predicate Device 510(k) Number:… | 2023 |
| * | K201151 | O-Mec 690 Series LaparoscopesSummary page 4…510(k) Number: K223923 Product Name: HOPKINS Telescopes Secondary Predicate Device 510(k) Number: K201151 Product Name: O-Mec Laparoscopes 690 Series… | 2020 |
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 24 years and passes through 3 companies; a new generation was cleared every 20.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.
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/K231003 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231003: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231003
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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