510(k) · Cleared
ClearedHans Hermann Laparoscopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Hermann GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 29, 2005 after a 42-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jul 29, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK051610 Hans Hermann Laparoscopes and AccessoriesHans Hermann GmbH · 2005
- Descendant · cites it directly · 1 of its ownK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK181173 ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated · 2019
- Descendant · 2 generations on · 0 of its ownK183264 Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK150024 Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH · 2015
- Descendant · cites it directly · 0 of its ownK060233 Trokamed GMBH Endoscopes and AccessoriesTrokamed GmbH · 2006
Most influential descendants
Showing 5 of 5 · See all- K100533Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models…Vibrynt, Inc. · 2011 · cites it directly1descendant
- K181173ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated · 2019 · cites it directly0descendants
- K183264Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. · 2019 · 2 generations on0descendants
- K150024Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH · 2015 · cites it directly0descendants
- K060233Trokamed GMBH Endoscopes and AccessoriesTrokamed GmbH · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051610 | Hans Hermann Laparoscopes and Accessories | Hans Hermann GmbH | 2005 | — |
| +1 | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
| +1 | K181173 | ELMED Laparoscopic Instruments and Accessories | Elmed Incorporated | 2019 | — |
| +2 | K183264 | Flex-THOR scope | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| +1 | K150024 | Bissinger Monopolar Cables | Guenter Bissinger Medizintechnik GmbH | 2015 | — |
| +1 | K060233 | Trokamed GMBH Endoscopes and Accessories | Trokamed GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | — | Ackermamn Named without a submission number | |
| * | — | ASAP Named without a submission number | |
| * | — | Richard Wolf Named without a submission number |
What descends from it? (5)
4 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, K100533 (Vibrynt, Inc., 2011) has gone furthest, with 1 descendant 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?
The Laparosopes and accessories are intended for use in providing access to and visualization ol 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 (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051610: Hans Hermann Laparoscopes 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/K051610
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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