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FDA 510(k)

NYLON THREADED NEEDLE

K-Number: K042367 · 2004-10-14

ApplicantAros Surgical Instruments Corp.
Decision Date2004-10-14
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NYLON THREADED NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Aros Surgical Instruments Corp.. It received FDA 510(k) clearance on 2004-10-14 under 510(k) number K042367. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NYLON THREADED NEEDLE?

NYLON THREADED NEEDLE is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Aros Surgical Instruments Corp.. The 510(k) number is K042367.

When did NYLON THREADED NEEDLE receive FDA 510(k) clearance?

NYLON THREADED NEEDLE received FDA 510(k) clearance on 2004-10-14, under 510(k) number K042367.

Who is the listed applicant for NYLON THREADED NEEDLE?

The FDA 510(k) record lists Aros Surgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYLON THREADED NEEDLE?

The FDA product code for NYLON THREADED NEEDLE is GAR.

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Related Devices (Code: GAR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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