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FDA 510(k)

HERNIA MESH STABILIZER

K-Number: K981598 · 1998-07-01

ApplicantMedivices Co.
Decision Date1998-07-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HERNIA MESH STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Medivices Co.. It received FDA 510(k) clearance on 1998-07-01 under 510(k) number K981598. 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 HERNIA MESH STABILIZER?

HERNIA MESH STABILIZER is a medical device that received FDA 510(k) clearance on 1998-07-01. The listed applicant is Medivices Co.. The 510(k) number is K981598.

When did HERNIA MESH STABILIZER receive FDA 510(k) clearance?

HERNIA MESH STABILIZER received FDA 510(k) clearance on 1998-07-01, under 510(k) number K981598.

Who is the listed applicant for HERNIA MESH STABILIZER?

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

What is the FDA product code for HERNIA MESH STABILIZER?

The FDA product code for HERNIA MESH STABILIZER 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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