FDA 510(k)

HAND STC, MODEL 60MM

K-Number: K042492 · 2004-10-19

ApplicantNiti Medical Technologies , Ltd.

Decision Date2004-10-19

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HAND STC, MODEL 60MM is the device name listed in this FDA 510(k) record. The listed applicant is Niti Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042492. 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 HAND STC, MODEL 60MM?

HAND STC, MODEL 60MM is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Niti Medical Technologies , Ltd.. The 510(k) number is K042492.

When did HAND STC, MODEL 60MM receive FDA 510(k) clearance?

HAND STC, MODEL 60MM received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042492.

Who is the listed applicant for HAND STC, MODEL 60MM?

The FDA 510(k) record lists Niti Medical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAND STC, MODEL 60MM?

The FDA product code for HAND STC, MODEL 60MM 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.