FDA 510(k)

PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X

K-Number: K910897 · 1991-04-01

Decision Date1991-04-01

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X is the device name listed in this FDA 510(k) record. The listed applicant is 3M Medical Products Group. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K910897. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X?

PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is 3M Medical Products Group. The 510(k) number is K910897.

When did PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X receive FDA 510(k) clearance?

PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X received FDA 510(k) clearance on 1991-04-01, under 510(k) number K910897.

Who is the listed applicant for PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X?

The FDA 510(k) record lists 3M Medical Products Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X?

The FDA product code for PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X is GDW.

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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.