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FDA 510(k)

PK ZIP WING CUTTING DISSECTOR

K-Number: K023493 · 2002-11-13

ApplicantGyrus Medical, Inc.
Decision Date2002-11-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PK ZIP WING CUTTING DISSECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical, Inc.. It received FDA 510(k) clearance on 2002-11-13 under 510(k) number K023493. 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 PK ZIP WING CUTTING DISSECTOR?

PK ZIP WING CUTTING DISSECTOR is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Gyrus Medical, Inc.. The 510(k) number is K023493.

When did PK ZIP WING CUTTING DISSECTOR receive FDA 510(k) clearance?

PK ZIP WING CUTTING DISSECTOR received FDA 510(k) clearance on 2002-11-13, under 510(k) number K023493.

Who is the listed applicant for PK ZIP WING CUTTING DISSECTOR?

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

What is the FDA product code for PK ZIP WING CUTTING DISSECTOR?

The FDA product code for PK ZIP WING CUTTING DISSECTOR is GEI.

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Other records listing Gyrus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050550GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATORK050460GYRUS PLASMACISION AND PLASMABLEND ELECTRODESK041999GYRUS PLASMA SKIN RESURFACING SYSTEMK041633GYRUS PLASMACISION LAPAROSCOPIC SPATULAK024286GYRUS OPEN FORCEPSK031085GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)

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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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