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FDA 510(k)

FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE

K-Number: K962554 · 1997-11-07

ApplicantAbbott Laboratories
Decision Date1997-11-07
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1997-11-07 under 510(k) number K962554. 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 FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE?

FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Abbott Laboratories. The 510(k) number is K962554.

When did FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE receive FDA 510(k) clearance?

FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE received FDA 510(k) clearance on 1997-11-07, under 510(k) number K962554.

Who is the listed applicant for FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE?

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

What is the FDA product code for FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE?

The FDA product code for FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE is KNT.

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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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