# KGC: Tube, Gastro-Enterostomy

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 182 days (middle half 136–228)
- Recalls: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 4
- 1998: 1
- 2008: 2
- 2009: 1
- 2012: 1
- 2017: 1
- 2019: 3
- 2020: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K080253: Kimberly-Clark Introducer Kits (2008), cited by 4
- K182832: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (2019), cited by 2
- K093312: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System (2009), cited by 2
- K183057: PUMA-G System (2019), cited by 1
- K901501: Corpak Gastrostomy Tube (1990), cited by 1
- K193612: AMT Suture Delivery System (2020), cited by 1
- K910584: One Step Button (TM) (1991), cited by 1
- K223916: PUMA-G System (2023), cited by 1

Source page: https://510kreport.com/product-code/KGC
Data by year (CSV): https://510kreport.com/product-code/KGC.csv