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FDA 510(k)

COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES

K-Number: K980079 · 1998-04-09

ApplicantLumenis, Inc.
Decision Date1998-04-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K980079. 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 COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES?

COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Lumenis, Inc.. The 510(k) number is K980079.

When did COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES receive FDA 510(k) clearance?

COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES received FDA 510(k) clearance on 1998-04-09, under 510(k) number K980079.

Who is the listed applicant for COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES?

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

What is the FDA product code for COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES?

The FDA product code for COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES is GCJ.

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Other records listing Lumenis, Inc. as applicant

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Related Devices (Code: GCJ)

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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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