COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE— 510(k) K981323
Substantially EquivalentNovartis Nutrition Corp.
FDA 510(k) clearance K981323 for COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE, Substantially Equivalent on 1998-10-09. Applicant: Novartis Nutrition Corp.. Device class: 2.
Clearance details
- Applicant
- Novartis Nutrition Corp.
- 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
- Minneapolis, MN, US
Recent devices under product code KNT
view allMore clearances from Novartis Nutrition Corp.
view all- K080340 — COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
- K071191 — NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT
- K001916 — COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
- K991668 — COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.