510(k) · Cleared
ClearedEndoscopic Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 5, 2003 as substantially equivalent to K913172 (Medco Products, Co., Inc., 1991) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Sep 5, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K913172 (1991). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913172 Endoscopic Delivery SystemMedco Products, Co., Inc. · 1991
- This deviceK031882 Endoscopic ApplicatorBaxter Healthcare Corp · 2003
- Descendant · cites it directly · 2 of its ownK120608 Endoscopic ApplicatorMicromedics, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK123847 Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK193137 EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K120608Endoscopic ApplicatorMicromedics, Inc. · 2012 · cites it directly2descendants
- K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013 · 2 generations on1descendant
- K193137EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913172 | Endoscopic Delivery System | Medco Products, Co., Inc. | 1991 | — |
| 0 (this device) | K031882 | Endoscopic Applicator | Baxter Healthcare Corp | 2003 | — |
| +1 | K120608 | Endoscopic Applicator | Micromedics, Inc. | 2012 | — |
| +2 | K123847 | Malleable Tip Endoscopic Applicator | Micromedics, Inc. | 2013 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K913172 | Endoscopic Delivery SystemSummary page 2…substantially equivalent to the following commercially available laparoscopic instruments: MedChem Surgical Endoscopic MedChem Products, Inc. K913172 Accessory/ Delivery System MedChem Surgical Delivery System MedChem Products, Inc. K932466 Davol Su… | 1991 |
| * | K932466 | Medchem Surgical Delivery SystemSummary page 2…cal Endoscopic MedChem Products, Inc. K913172 Accessory/ Delivery System MedChem Surgical Delivery System MedChem Products, Inc. K932466 Davol Surgical Mesh Delivery System Davol, Inc. K930147 The Endoscopic Applicator and the predica… | 1993 |
| * | K930147 | Surgical Mesh Delivery System, General SurgerySummary page 2…livery System MedChem Surgical Delivery System MedChem Products, Inc. K932466 Davol Surgical Mesh Delivery System Davol, Inc. K930147 The Endoscopic Applicator and the predicate devices have similar intended uses. They are all intended to deliver surgi… | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120608 | Endoscopic Applicator | 2012 | 2 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K120608 (Micromedics, Inc., 2012) has gone furthest, with 2 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?
This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.
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/K031882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031882: 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/K031882
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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