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FDA 510(k)

Surgical Direct Hand-held Laparoscopic Instruments

K-Number: K193018 · 2019-12-20

ApplicantSurgical Direct, Inc.
Decision Date2019-12-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Direct Hand-held Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Direct, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193018. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Direct Hand-held Laparoscopic Instruments?

Surgical Direct Hand-held Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Surgical Direct, Inc.. The 510(k) number is K193018.

When did Surgical Direct Hand-held Laparoscopic Instruments receive FDA 510(k) clearance?

Surgical Direct Hand-held Laparoscopic Instruments received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193018.

Who is the listed applicant for Surgical Direct Hand-held Laparoscopic Instruments?

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

What is the FDA product code for Surgical Direct Hand-held Laparoscopic Instruments?

The FDA product code for Surgical Direct Hand-held Laparoscopic Instruments is GEI.

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Official Source

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