510(k) · Cleared
ClearedMicromedics Fibrijet Air Assisted Endoscopic Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedics, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 11, 2005 after a 121-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 121 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK042834 Micromedics Fibrijet Air Assisted Endoscopic ApplicatorMicromedics, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK123325 Medafor Direct Gas-Assisted Application SystemMedafor, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK122526 360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK162197 EndoClotEndoclot Plus Co., Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK190677 EndoClotEndoclot Plus Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK123847 Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K123325Medafor Direct Gas-Assisted Application SystemMedafor, Inc. · 2013 · cites it directly3descendants
- K122526360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012 · cites it directly3descendants
- K162197EndoClotEndoclot Plus Co., Ltd. · 2017 · 2 generations on2descendants
- K190677EndoClotEndoclot Plus Co., Ltd. · 2021 · 3 generations on1descendant
- K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042834 | Micromedics Fibrijet Air Assisted Endoscopic Applicator | Micromedics, Inc. | 2005 | — |
| +1 | K123325 | Medafor Direct Gas-Assisted Application System | Medafor, Inc. | 2013 | — |
| +1 | K122526 | 360 Gas Assisted Endoscopic Applicator | Micromedics, Inc. | 2012 | — |
| +2 | K162197 | EndoClot | Endoclot Plus Co., Ltd. | 2017 | — |
| +3 | K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021 | — |
| +2 | K123847 | Malleable Tip Endoscopic Applicator | Micromedics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
3 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, K123325 (Medafor, Inc., 2013) has gone furthest, with 3 descendants 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 Endoscopic Spray Applicator is intended to be used for the application of two non-homogeneous fluids to a treatment site.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042834: Micromedics Fibrijet Air Assisted Endoscopic Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042834
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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