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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 a medical device manufactured by Surgical Direct, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval 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. It is manufactured by Surgical Direct, Inc.. The 510(k) number is K193018.

When was Surgical Direct Hand-held Laparoscopic Instruments approved by the FDA?

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

What company makes Surgical Direct Hand-held Laparoscopic Instruments?

Surgical Direct Hand-held Laparoscopic Instruments is manufactured by Surgical Direct, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025)

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Official Source

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