510(k) · Cleared
ClearedAMT Suture Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · KGC Tube, Gastro-Enterostomy
Cleared on Mar 12, 2020 as substantially equivalent to K182832 (Cook Incorporated, 2019) after a 77-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Mar 12, 2020
- Review
- 77 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873606 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK873606 Modified Cope Suture AnchorCook, Inc. · 1988
- 1 generation backK182832 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy…Cook Incorporated · 2019
- This deviceK193612 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 1 of 1 · See all- K241111AMT Suture PasserApplied Medical Technology, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873606 | Modified Cope Suture Anchor | Cook, Inc. | 1988 | — |
| −1 | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | 2019 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetSummary page 4…Classification Name: Gastrointestinal tube and accessories (21 CFR 876.5980) Product Code: KGC Regulatory Class: Class II III. PREDICATE INFORMATION: Predicate Device: K182832, Enterostomy Suture Anchor Set (Cook, Inc.; cleared on June 26, 2019). **This predicate devices has not been subject to design-r… | 2019 |
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 |
|---|---|---|---|
| K241111 | AMT Suture Passer | 2024 | 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 32 years and passes through 3 companies; a new generation was cleared every 31.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241111 (Applied Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182832.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 AMT Suture Delivery System 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/K193612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193612: AMT Suture Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193612
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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