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FDA 510(k)

SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE

K-Number: K113763 · 2012-03-16

ApplicantNobles Medical Technologies Ii, Inc.
Decision Date2012-03-16
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Nobles Medical Technologies Ii, Inc.. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K113763. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE?

SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Nobles Medical Technologies Ii, Inc.. The 510(k) number is K113763.

When did SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE receive FDA 510(k) clearance?

SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE received FDA 510(k) clearance on 2012-03-16, under 510(k) number K113763.

Who is the listed applicant for SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE?

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

What is the FDA product code for SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE?

The FDA product code for SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE is GAW.

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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.

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