510(k) · Cleared
ClearedCCD Endocam 5501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 4, 1995 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.
- Decided
- May 4, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK950502 CCD Endocam 5501Richard Wolf Medical Instruments Corp. · 1995
- Descendant · cites it directly · 11 of its ownK983279 Endocam Camera Systems 5502 with Electronic CCD EndoscopeRichard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 11 of its ownK982965 Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 10 of its ownK023659 1-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003
- Descendant · 2 generations on · 7 of its ownK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- Descendant · 2 generations on · 6 of its ownK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K983279Endocam Camera Systems 5502 with Electronic CCD EndoscopeRichard Wolf Medical Instruments Corp. · 1998 · cites it directly11descendants
- K982965Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp. · 1998 · cites it directly11descendants
- K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003 · cites it directly10descendants
- K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008 · 2 generations on7descendants
- K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950502 | CCD Endocam 5501 | Richard Wolf Medical Instruments Corp. | 1995 | — |
| +1 | K983279 | Endocam Camera Systems 5502 with Electronic CCD Endoscope | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K023659 | 1-CCD Endocam 5520 System | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +2 | K080977 | 3 CCD Endocam 5550 | Richard Wolf Medical Instruments Corp. | 2008 | — |
| +2 | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525 | Richard Wolf Medical Instruments Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 144 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, K983279 (Richard Wolf Medical Instruments Corp., 1998) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K950502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950502: CCD Endocam 5501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950502
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026