# K882867: Corpak Percutaneous Endoscopic Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Corpak Co.
- Decided: Sep 21, 1988 after 72 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 30, 2026 · Class II · Z-2340-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2335-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2334-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2338-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2333-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2337-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2336-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Apr 30, 2026 · Class II · Z-2339-2026: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Mar 16, 2020 · Class II · Z-1822-2020: The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
- Oct 8, 2019 · Class II · Z-0370-2020: The connector piece to the PEG tube does not pass over the guidewire.
- Oct 8, 2019 · Class II · Z-0371-2020: The connector piece to the PEG tube does not pass over the guidewire.
- Feb 3, 2017 · Class II · Z-2162-2017: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
- Feb 3, 2017 · Class II · Z-2163-2017: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
- Feb 3, 2017 · Class II · Z-2161-2017: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

Source page: https://510kreport.com/device/K882867
Methodology: https://510kreport.com/methodology