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FDA 510(k)

TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM

K-Number: K002583 · 2001-02-13

ApplicantVidamed, Inc.
Decision Date2001-02-13
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TUNA (TRANS URETHRA NEEDLE) 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 2001-02-13 under 510(k) number K002583. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM?

TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-13. The listed applicant is Vidamed, Inc.. The 510(k) number is K002583.

When did TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM receive FDA 510(k) clearance?

TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM received FDA 510(k) clearance on 2001-02-13, under 510(k) number K002583.

Who is the listed applicant for TUNA (TRANS URETHRA NEEDLE) 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 TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM?

The FDA product code for TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM is KNS.

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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.

K014224PRECISION PLUS TUNA OFFICE SYSTEMK012587RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPEK011787PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPEK973366COBRA HAND PIECEK965199TUNA 5 CATHETERK965061VIDAMED MODEDL 7600 RF GENERATOR

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Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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