510(k) · Cleared
Cleared3 CCD Endocam 5550
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 14, 2008 as substantially equivalent to K063457 (Conmed Linvatec, 2006) and 1 other predicate after a 37-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.
- Decided
- May 14, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K950862 (1995). 12 ancestors in all, the oldest K942817 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 3 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 2 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 1 generation backK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
- This deviceK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- Descendant · cites it directly · 6 of its ownK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
- Descendant · 3 generations on · 2 of its ownK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK252858 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013 · cites it directly6descendants
- K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018 · 2 generations on4descendants
- K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation · 2020 · 3 generations on2descendants
- K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −3 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −2 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −1 | K063457 | Truehd (1080P) Digital Camera System | Conmed Linvatec | 2006 | — |
| 0 (this device) | K080977 | 3 CCD Endocam 5550 | Richard Wolf Medical Instruments Corp. | 2008 | — |
| +1 | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525 | Richard Wolf Medical Instruments Corp. | 2013 | — |
| +2 | K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corporation | 2018 | — |
| +3 | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera… | Richard Wolf Medical Instruments Corporation | 2020 | — |
| +3 | K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026 | — |
| +3 | K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K063457 | Truehd (1080P) Digital Camera SystemSummary page 1…Product Code GCJ) Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer 1 K063457 1 TrueHD Digital Camera System 1 ConMed Linvatec… | 2006 |
| * | K023659 | 1-CCD Endocam 5520 SystemSummary page 1…gital Camera System 1 ConMed Linvatec 2 Richard Wolf Medical Instruments 2 K023659 2 1 CCD Endocam 5520 System Corp. Device… | 2003 |
What descends from it? (7)
2 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 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K130423 (Richard Wolf Medical Instruments Corp., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K063457.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 3 CCD HID ENDOCAM 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images.
The 3 CCD Endocam is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080977 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080977: 3 CCD Endocam 5550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080977
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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