FDA 510(k)

AUTOTOME RX MODEL # 4515, 4516

K-Number: K013153 · 2001-10-19

Decision Date2001-10-19

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AUTOTOME RX MODEL # 4515, 4516 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2001-10-19 under 510(k) number K013153. 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 AUTOTOME RX MODEL # 4515, 4516?

AUTOTOME RX MODEL # 4515, 4516 is a medical device that received FDA 510(k) clearance on 2001-10-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K013153.

When did AUTOTOME RX MODEL # 4515, 4516 receive FDA 510(k) clearance?

AUTOTOME RX MODEL # 4515, 4516 received FDA 510(k) clearance on 2001-10-19, under 510(k) number K013153.

Who is the listed applicant for AUTOTOME RX MODEL # 4515, 4516?

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

What is the FDA product code for AUTOTOME RX MODEL # 4515, 4516?

The FDA product code for AUTOTOME RX MODEL # 4515, 4516 is KNS.

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Related Devices (Code: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.