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FDA 510(k)

GASTROPORT II

K-Number: K924308 · 1993-07-29

ApplicantSandoz Nutrition
Decision Date1993-07-29
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

GASTROPORT II is the device name listed in this FDA 510(k) record. The listed applicant is Sandoz Nutrition. It received FDA 510(k) clearance on 1993-07-29 under 510(k) number K924308. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GASTROPORT II?

GASTROPORT II is a medical device that received FDA 510(k) clearance on 1993-07-29. The listed applicant is Sandoz Nutrition. The 510(k) number is K924308.

When did GASTROPORT II receive FDA 510(k) clearance?

GASTROPORT II received FDA 510(k) clearance on 1993-07-29, under 510(k) number K924308.

Who is the listed applicant for GASTROPORT II?

The FDA 510(k) record lists Sandoz Nutrition as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GASTROPORT II?

The FDA product code for GASTROPORT II is KNT.

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Other records listing Sandoz Nutrition as applicant

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K965087COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)K961664COMPAT NASOJEJUNAL FEEDING TUBEK940555SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONK940556SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMPK923983PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KITK915308PEG GASTROSTOMY TUBE KIT

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Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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