510(k) · Cleared
ClearedTrokamed GMBH Endoscopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trokamed GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 19, 2006 as substantially equivalent to K991718 (Richard Wolf Medical Instruments Corp., 1999) and 2 other predicates after a 170-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jul 19, 2006
- Review
- 170 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K932540 (1994). 4 ancestors in all. 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 | K932540 | Laporascopic Surgical Instruments /General Use | Advanced Surgical, Inc. | 1994 | — |
| −1 | K974382 | Ackermann Surgical Instruments | Ackermann Instrumente GmbH | 1998 | — |
| 0 (this device) | K060233 | Trokamed GMBH Endoscopes and Accessories | Trokamed GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K991718 | Operating Laparoscope, 10-5 MM, Angeled, Operating Laparoscope 12-7MM, Angled, Operating…Summary page 2…ilized and reused. 4. SUBSTANTIAL EQUIVALENCE Manufacturer 510(k) Number Device name A Richard Wolf K991718 Operating Laparoscope, 10-5mm, angeled... B Hans Hermann K051610 L… | 1999 |
| * | K051610 | Hans Hermann Laparoscopes and AccessoriesSummary page 2…Device name A Richard Wolf K991718 Operating Laparoscope, 10-5mm, angeled... B Hans Hermann K051610 Laparoscopes and accessories C Ackermann K 974382 Ackermann surg… | 2005 |
| * | K974382 | Ackermann Surgical InstrumentsSummary page 2…aparoscope, 10-5mm, angeled... B Hans Hermann K051610 Laparoscopes and accessories C Ackermann K 974382 Ackermann surgical instruments 5. BIocoMPATIBILITY The biocompatibility has been approved based on ISO 10993 pa… | 1998 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K991718.
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?
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures. The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle and elbow.…
Read the full statement (109 words)
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures.
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle and elbow.
The cystoscopes and accessories are used for visualizing body cavities end organs (via natural passages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope's working channel.
The instruments are reusable; they are intended to be cleaned, sterilized and reused.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060233: Trokamed GMBH Endoscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060233
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