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FDA 510(k)

PAPILLOTOME

K-Number: K851652 · 1985-06-24

ApplicantMicrovasive
Decision Date1985-06-24
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PAPILLOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Microvasive. It received FDA 510(k) clearance on 1985-06-24 under 510(k) number K851652. 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 PAPILLOTOME?

PAPILLOTOME is a medical device that received FDA 510(k) clearance on 1985-06-24. The listed applicant is Microvasive. The 510(k) number is K851652.

When did PAPILLOTOME receive FDA 510(k) clearance?

PAPILLOTOME received FDA 510(k) clearance on 1985-06-24, under 510(k) number K851652.

Who is the listed applicant for PAPILLOTOME?

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

What is the FDA product code for PAPILLOTOME?

The FDA product code for PAPILLOTOME is KNS.

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Other records listing Microvasive 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.

K872771LOW PROFILE GASTROSTOMYK870705THERMAL COAGULATORK861309JEJUNAL FEEDING TUBEK861323REPLACEMENT GASTROSTOMY TUBEK860366CHALLENGER HOT BIOPSY FORCEPSK860589INFLATOR/DEFLATOR PISTON SYRINGE

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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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