510(k) · Cleared
ClearedTrocasys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 17, 2007 as substantially equivalent to K012771 (Pajunk GmbH, 2001) after a 56-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jan 17, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012771 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K080654Pajunk's Kit for Balloon Aided LaparoscopyPAJUNK GmbH Medizintechnologie · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012771 | Trocar Sleeve and Accessories, Models 1287-XX-XX | Pajunk GmbH | 2001 | — |
| 0 (this device) | K063528 | Trocasys | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +1 | K080654 | Pajunk's Kit for Balloon Aided Laparoscopy | PAJUNK GmbH Medizintechnologie | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K012771 | Trocar Sleeve and Accessories, Models 1287-XX-XXSummary page 1…Number: Classification: Regulatory Class: 11 Product Code: GCJ Panel: General & Plastic Surgery Predicate Devices: K01 2771: Pajunks reusable Trocars, trocar sleeves, dilation balloons and trocar Systems PMN… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080654 | Pajunk's Kit for Balloon Aided Laparoscopy | 2008 | 0 |
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063528: Trocasys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063528
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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