510(k) · Cleared
ClearedMalleable Tip 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 Jan 8, 2013 as substantially equivalent to K120608 (Micromedics, Inc., 2012) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jan 8, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913172 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK913172 Endoscopic Delivery SystemMedco Products, Co., Inc. · 1991
- 2 generations backK031882 Endoscopic ApplicatorBaxter Healthcare Corp · 2003
- 1 generation backK120608 Endoscopic ApplicatorMicromedics, Inc. · 2012
- This deviceK123847 Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK193137 EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K193137EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913172 | Endoscopic Delivery System | Medco Products, Co., Inc. | 1991 | — |
| −2 | K031882 | Endoscopic Applicator | Baxter Healthcare Corp | 2003 | — |
| −1 | K120608 | Endoscopic Applicator | Micromedics, Inc. | 2012 | — |
| 0 (this device) | K123847 | Malleable Tip Endoscopic Applicator | Micromedics, Inc. | 2013 | — |
| +1 | K193137 | EASYGRIP FLO-41 Precision MIS Delivery System | Baxter Healthcare Corportation | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2005 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K120608 | Endoscopic ApplicatorSummary page 1…ode GCJ 1nforfil6tion per 21 CFR 876.1500 (Class 11) -panel General & Plastic Surgery Predicate Endoscopic Applicator, K120608 cleared on March 15, 2012 Devices 3600 Gas Assisted Endoscopic Applicator, K122526, cleared on November 16,… | 2012 |
| * | K122526 | 360 Gas Assisted Endoscopic ApplicatorSummary page 1…astic Surgery Predicate Endoscopic Applicator, K120608 cleared on March 15, 2012 Devices 3600 Gas Assisted Endoscopic Applicator, K122526, cleared on November 16, 2012 Device Description The Malleable Tip Endoscopic Applicator is a sterile, single-use, disposable de… | 2012 |
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 |
|---|---|---|---|
| K193137 | EASYGRIP FLO-41 Precision MIS Delivery System | 2020 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K193137 (Baxter Healthcare Corportation, 2020) has gone furthest, with 0 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. 2013, 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 Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding
surgical sites through a 5 mm or larger trocar.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123847: Malleable Tip 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/K123847
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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