FEEDING TUBE— 510(k) K896734

Name: FDA 510(k) clearance K896734
Creator: U.S. Food and Drug Administration
Published: 1990-12-21

Substantially Equivalent

Unoplast A/S

FDA 510(k) clearance K896734 for FEEDING TUBE, Substantially Equivalent on 1990-12-21. Applicant: Unoplast A/S. Device class: 2.

Clearance details

Applicant: Unoplast A/S
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-30
Decision date: 1990-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPD

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K243361 — Nutrifit2024-12-19
K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)2019-01-18
K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE2013-10-23
K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE2013-03-06
K121105 — NUTRISAFE 2 FEEDING TUBE2012-12-18

More clearances from Unoplast A/S

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K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER1990-11-05
K896732 — UNOMETER 5001990-11-02
K896730 — SUCTION CATHETER STRAIGHT/COUDE1990-03-30
K896731 — OXYGEN CATHETERS1990-03-30
K896733 — VACCON1990-02-01

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K896734

K-number listed on FDA's recall record

Z-1036-2019 — Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.Class II·Ongoing·ConvaTec, Inc·20190109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K896734.

Data sourced from openFDA. This site is unofficial and independent of the FDA.