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FDA 510(k)

HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE

K-Number: K861904 · 1986-10-16

ApplicantCooper Lasersonics, Inc.
Decision Date1986-10-16
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1986-10-16 under 510(k) number K861904. 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 HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE?

HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE is a medical device that received FDA 510(k) clearance on 1986-10-16. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K861904.

When did HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE receive FDA 510(k) clearance?

HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE received FDA 510(k) clearance on 1986-10-16, under 510(k) number K861904.

Who is the listed applicant for HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE?

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

What is the FDA product code for HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE?

The FDA product code for HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE is KNS.

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Other records listing Cooper Lasersonics, Inc. as applicant

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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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