FDA 510(k)

CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L

K-Number: K090821 · 2009-06-10

ApplicantFrankenman International Limited

Decision Date2009-06-10

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L is the device name listed in this FDA 510(k) record. The listed applicant is Frankenman International Limited. It received FDA 510(k) clearance on 2009-06-10 under 510(k) number K090821. 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 CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L?

CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L is a medical device that received FDA 510(k) clearance on 2009-06-10. The listed applicant is Frankenman International Limited. The 510(k) number is K090821.

When did CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L receive FDA 510(k) clearance?

CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L received FDA 510(k) clearance on 2009-06-10, under 510(k) number K090821.

Who is the listed applicant for CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L?

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

What is the FDA product code for CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L?

The FDA product code for CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L is GDW.

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Official Source

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