FDA 510(k)

REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C

K-Number: K071023 · 2008-08-28

Decision Date2008-08-28

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C is the device name listed in this FDA 510(k) record. The listed applicant is Reach Surgical, Inc.. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K071023. 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 REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C?

REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Reach Surgical, Inc.. The 510(k) number is K071023.

When did REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C receive FDA 510(k) clearance?

REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C received FDA 510(k) clearance on 2008-08-28, under 510(k) number K071023.

Who is the listed applicant for REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C?

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

What is the FDA product code for REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C?

The FDA product code for REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C 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.