FDA 510(k)

NON-BALLOON REPLACEMENT GASTROSTOMY KIT

K-Number: K932295 · 1994-09-08

ApplicantBiosearch Medical Products, Inc.

Decision Date1994-09-08

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NON-BALLOON REPLACEMENT GASTROSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1994-09-08 under 510(k) number K932295. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-BALLOON REPLACEMENT GASTROSTOMY KIT?

NON-BALLOON REPLACEMENT GASTROSTOMY KIT is a medical device that received FDA 510(k) clearance on 1994-09-08. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K932295.

When did NON-BALLOON REPLACEMENT GASTROSTOMY KIT receive FDA 510(k) clearance?

NON-BALLOON REPLACEMENT GASTROSTOMY KIT received FDA 510(k) clearance on 1994-09-08, under 510(k) number K932295.

Who is the listed applicant for NON-BALLOON REPLACEMENT GASTROSTOMY KIT?

The FDA 510(k) record lists Biosearch Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-BALLOON REPLACEMENT GASTROSTOMY KIT?

The FDA product code for NON-BALLOON REPLACEMENT GASTROSTOMY KIT is KNT.

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Official Source

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