510(k) · Cleared
ClearedTrocar Sleeve and Accessories, Models 1287-XX-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 14, 2001 after an 89-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Nov 14, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK012771 Trocar Sleeve and Accessories, Models 1287-XX-XXPajunk GmbH · 2001
- Descendant · cites it directly · 1 of its ownK063528 TrocasysPAJUNK GmbH Medizintechnologie · 2007
- Descendant · cites it directly · 0 of its ownK080654 Pajunk's Kit for Balloon Aided LaparoscopyPAJUNK GmbH Medizintechnologie · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012771 | Trocar Sleeve and Accessories, Models 1287-XX-XX | Pajunk GmbH | 2001 | — |
| +1 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (2)
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?
- Of its descendants, K063528 (PAJUNK GmbH Medizintechnologie, 2007) 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?
Manually operated surgical device intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures Manually operated surgical device intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures Manually operated surgical device intended for…
Read the full statement (113 words)
Manually operated surgical device intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
Manually operated surgical device intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
Manually operated surgical device intended for providing a well anchored and tight instrument channel to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012771: Trocar Sleeve and Accessories, Models 1287-XX-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012771
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026