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FDA 510(k)

CHALLENGER HOT BIOPSY FORCEPS

K-Number: K860366 · 1986-04-07

ApplicantMicrovasive
Decision Date1986-04-07
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHALLENGER HOT BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Microvasive. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K860366. 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 CHALLENGER HOT BIOPSY FORCEPS?

CHALLENGER HOT BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Microvasive. The 510(k) number is K860366.

When did CHALLENGER HOT BIOPSY FORCEPS receive FDA 510(k) clearance?

CHALLENGER HOT BIOPSY FORCEPS received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860366.

Who is the listed applicant for CHALLENGER HOT BIOPSY FORCEPS?

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 CHALLENGER HOT BIOPSY FORCEPS?

The FDA product code for CHALLENGER HOT BIOPSY FORCEPS 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 COAGULATORK861323REPLACEMENT GASTROSTOMY TUBEK861309JEJUNAL FEEDING TUBEK860589INFLATOR/DEFLATOR PISTON SYRINGEK854238NEEDLE W/STYLET FOR IMPLANTATION

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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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