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FDA 510(k)

INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150

K-Number: K990663 · 1999-05-27

ApplicantMedtech , Ltd.
Decision Date1999-05-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 is the device name listed in this FDA 510(k) record. The listed applicant is Medtech , Ltd.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K990663. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150?

INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Medtech , Ltd.. The 510(k) number is K990663.

When did INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 receive FDA 510(k) clearance?

INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 received FDA 510(k) clearance on 1999-05-27, under 510(k) number K990663.

Who is the listed applicant for INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150?

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

What is the FDA product code for INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150?

The FDA product code for INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 is GCJ.

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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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