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FDA 510(k)

Pakter Curved Needle Set

K-Number: K173155 · 2018-06-07

ApplicantCook Incorporated
Decision Date2018-06-07
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pakter Curved Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K173155. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pakter Curved Needle Set?

Pakter Curved Needle Set is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Cook Incorporated. The 510(k) number is K173155.

When did Pakter Curved Needle Set receive FDA 510(k) clearance?

Pakter Curved Needle Set received FDA 510(k) clearance on 2018-06-07, under 510(k) number K173155.

Who is the listed applicant for Pakter Curved Needle Set?

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

What is the FDA product code for Pakter Curved Needle Set?

The FDA product code for Pakter Curved Needle Set is BSP.

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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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