CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE— 510(k) K882867
Substantially EquivalentCorpak Co.
FDA 510(k) clearance K882867 for CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE, Substantially Equivalent on 1988-09-21. Applicant: Corpak Co.. Device class: 2.
Clearance details
- Applicant
- Corpak Co.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheeling, IL, US
Recent devices under product code KNT
view allMore clearances from Corpak Co.
view allAdverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K882867
K-number listed on FDA's recall record- Z-2333-2026 — Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
- Z-2334-2026 — Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
- Z-2335-2026 — Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
- Z-2336-2026 — Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
- Z-2337-2026 — Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
- Z-2338-2026 — Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
- Z-2339-2026 — Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
- Z-2340-2026 — Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
- Z-1822-2020 — CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
- Z-0370-2020 — CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
- Z-0371-2020 — CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
- Z-2161-2017 — CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
- Z-2162-2017 — CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
- Z-2163-2017 — CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882867.
Data sourced from openFDA. This site is unofficial and independent of the FDA.