Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OsteoCool V-3 RF Ablation System

K-Number: K161949 · 2017-01-31

ApplicantBaylis Medical Company, Inc.
Decision Date2017-01-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OsteoCool V-3 RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K161949. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoCool V-3 RF Ablation System?

OsteoCool V-3 RF Ablation System is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K161949.

When did OsteoCool V-3 RF Ablation System receive FDA 510(k) clearance?

OsteoCool V-3 RF Ablation System received FDA 510(k) clearance on 2017-01-31, under 510(k) number K161949.

Who is the listed applicant for OsteoCool V-3 RF Ablation System?

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

What is the FDA product code for OsteoCool V-3 RF Ablation System?

The FDA product code for OsteoCool V-3 RF Ablation System is GEI.

Other records listing Baylis Medical Company, 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.

K251325VersaCross Connect™ Transseptal DilatorK242076VersaCross™ RF WireK241720VersaCross Connect™ Transseptal DilatorK231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathK233647VersaCross Connect™ Transseptal DilatorK213898ProTrack Pigtail Wire

View all 19 devices →

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑