510(k) · Decided
DecidedCope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KGC Tube, Gastro-Enterostomy
Cleared on Jun 26, 2019 as substantially equivalent to K873606 (Cook, Inc., 1988) after a 260-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Jun 26, 2019
- Review
- 260 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873606 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK873606 Modified Cope Suture AnchorCook, Inc. · 1988
- This deviceK182832 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy…Cook Incorporated · 2019
- Descendant · cites it directly · 1 of its ownK193612 AMT Suture Delivery SystemApplied Medical Technology, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK241111 AMT Suture PasserApplied Medical Technology, Inc. · 2024
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 |
|---|---|---|---|---|---|
| −1 | K873606 | Modified Cope Suture Anchor | Cook, Inc. | 1988 | — |
| 0 (this device) | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | 2019 | — |
| +1 | K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | 2020 | — |
| +1 | K241111 | AMT Suture Passer | Applied Medical Technology, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 KGC? 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 KGC device
- #1 K242211 PUMA-G Pediatric Systemscore 10.5 · 5 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 |
|---|---|---|---|
| * | K873606 | Modified Cope Suture AnchorSummary page 5…Predicate Device: The predicate device for the Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set is the Modified Cope Suture Anchor (K873606, Cook Incorporated) cleared on June 17, 1988. Device Description: This bundled submission includes two devices: Cope Pediatric… | 1988 |
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?
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KGC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGC
159in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGC
106in 2025
MAUDE reports naming product code KGC, 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 | 0 | — | 0 | 12 |
| 2008 | 2 | — | 0 | 30 |
| 2009 | 1 | — | 5 | 47 |
| 2010 | 0 | — | 6 | 67 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 41 |
| 2015 | 0 | — | 1 | 72 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 1 | — | 0 | 102 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 3 | 159 | 0 | 90 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 0 | — | 0 | 73 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 1 | — | 0 | 106 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cope Pediatric Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters and can stay in place for up to 14 days in infant, child, and adolescent populations.
The Enterostomy Suture Anchor Set is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182832: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182832
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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