510(k) · Cleared
Cleared360 Gas 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 Nov 16, 2012 as substantially equivalent to K042834 (Micromedics, Inc., 2005) after an 88-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.
- Decided
- Nov 16, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042834 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042834 Micromedics Fibrijet Air Assisted Endoscopic ApplicatorMicromedics, Inc. · 2005
- This deviceK122526 360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK123847 Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK193137 EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK162077 Laparoscopic Spray Applicator with Spinning LuersMicromedics, Inc. (D/B/A Nordson Medical) · 2016
Most influential descendants
Showing 3 of 3 · See all- K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013 · cites it directly1descendant
- K193137EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 2020 · 2 generations on0descendants
- K162077Laparoscopic Spray Applicator with Spinning LuersMicromedics, Inc. (D/B/A Nordson Medical) · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042834 | Micromedics Fibrijet Air Assisted Endoscopic Applicator | Micromedics, Inc. | 2005 | — |
| 0 (this device) | K122526 | 360 Gas Assisted Endoscopic Applicator | Micromedics, Inc. | 2012 | — |
| +1 | K123847 | Malleable Tip Endoscopic Applicator | Micromedics, Inc. | 2013 | — |
| +2 | K193137 | EASYGRIP FLO-41 Precision MIS Delivery System | Baxter Healthcare Corportation | 2020 | 1 |
| +1 | K162077 | Laparoscopic Spray Applicator with Spinning Luers | Micromedics, Inc. (D/B/A Nordson Medical) | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K042834 | Micromedics Fibrijet Air Assisted Endoscopic ApplicatorSummary page 1…GCJ Information per 21 CFR 876.1500 (Class 11) Panel General & Plastic Surgery Predicate Air Assisted Endoscopic Applicator, K042834 cleared on February 11, 2005 Devices Device Description The 360' Gas Assisted Endoscopic Applicator is a sterile, single-use,… | 2005 |
What descends from it? (3)
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 3600 Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122526: 360 Gas Assisted Endoscopic Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122526
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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