510(k) · Cleared
ClearedEntuit Start Initial Placement Gastrostomy 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 Sep 14, 2017 as substantially equivalent to K080253 (Kimberly-Clark Corp., 2008) after a 225-day review. Its family tree reaches back 2 generations to 1985. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 14, 2017
- Review
- 225 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852363 (1985). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK852363 Mic Gastrostomy Tube Percutaneous Insertion KitMedical Innovations Corp. · 1985
- 1 generation backK080253 Kimberly-Clark Introducer KitsKimberly-Clark Corp. · 2008
- This deviceK170323 Entuit Start Initial Placement Gastrostomy SetCook Incorporated · 2017
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification2 generations back · 1994
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852363 | Mic Gastrostomy Tube Percutaneous Insertion Kit | Medical Innovations Corp. | 1985 | — |
| −1 | K080253 | Kimberly-Clark Introducer Kits | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K170323 | Entuit Start Initial Placement Gastrostomy Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K080253 | Kimberly-Clark Introducer KitsSummary page 4…Gastroenterology/Urology Predicate Device: The Entuit™ Start Initial Placement Gastrostomy Set is substantially equivalent to the Kimberly-Clark Introducer Kits (K080253), cleared by FDA on February 26, 2008. Device Description: The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K921370Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 1994 · 2 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K080253.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170323: Entuit Start Initial Placement Gastrostomy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170323
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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