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FDA 510(k)

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX

K-Number: K080946 · 2008-05-20

ApplicantConmed Endoscopic Technologies, Inc.
Decision Date2008-05-20
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Endoscopic Technologies, Inc.. It received FDA 510(k) clearance on 2008-05-20 under 510(k) number K080946. 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 CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX?

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX is a medical device that received FDA 510(k) clearance on 2008-05-20. The listed applicant is Conmed Endoscopic Technologies, Inc.. The 510(k) number is K080946.

When did CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX receive FDA 510(k) clearance?

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX received FDA 510(k) clearance on 2008-05-20, under 510(k) number K080946.

Who is the listed applicant for CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX?

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

What is the FDA product code for CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX?

The FDA product code for CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX is KNS.

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Other records listing Conmed Endoscopic Technologies, 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.

K091355DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998

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

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