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FDA 510(k)

PRECISION PLUS TUNA OFFICE SYSTEM

K-Number: K014224 · 2002-01-23

ApplicantVidamed, Inc.
Decision Date2002-01-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRECISION PLUS TUNA OFFICE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vidamed, Inc.. It received FDA 510(k) clearance on 2002-01-23 under 510(k) number K014224. 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 PRECISION PLUS TUNA OFFICE SYSTEM?

PRECISION PLUS TUNA OFFICE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-23. The listed applicant is Vidamed, Inc.. The 510(k) number is K014224.

When did PRECISION PLUS TUNA OFFICE SYSTEM receive FDA 510(k) clearance?

PRECISION PLUS TUNA OFFICE SYSTEM received FDA 510(k) clearance on 2002-01-23, under 510(k) number K014224.

Who is the listed applicant for PRECISION PLUS TUNA OFFICE SYSTEM?

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

What is the FDA product code for PRECISION PLUS TUNA OFFICE SYSTEM?

The FDA product code for PRECISION PLUS TUNA OFFICE SYSTEM is GEI.

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Other records listing Vidamed, 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.

K012587RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPEK011787PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPEK002583TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEMK973366COBRA HAND PIECEK965199TUNA 5 CATHETERK965061VIDAMED MODEDL 7600 RF GENERATOR

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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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