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

FDA 510(k)

Stryker iVAS 13g Bone Biopsy Kit

K-Number: K180327 · 2018-02-26

ApplicantStryker Corporation
Decision Date2018-02-26
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stryker iVAS 13g Bone Biopsy Kit is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2018-02-26 under approval number K180327. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker iVAS 13g Bone Biopsy Kit?

Stryker iVAS 13g Bone Biopsy Kit is a medical device that received FDA 510(k) clearance on 2018-02-26. It is manufactured by Stryker Corporation. The 510(k) number is K180327.

When was Stryker iVAS 13g Bone Biopsy Kit approved by the FDA?

Stryker iVAS 13g Bone Biopsy Kit received FDA 510(k) clearance on 2018-02-26, under approval number K180327.

What company makes Stryker iVAS 13g Bone Biopsy Kit?

Stryker iVAS 13g Bone Biopsy Kit is manufactured by Stryker Corporation.

What is the FDA product code for Stryker iVAS 13g Bone Biopsy Kit?

The FDA product code for Stryker iVAS 13g Bone Biopsy Kit is KNW.

Other Devices by Stryker Corporation

K162062AVAmax Vertebral Balloon, AVAflex Vertebral Balloon K160715AccuLIF TL and PL Cage K160978LITe BIO Delivery System K160050SERFAS 90-S Electrosurgical Probe K153407Stryker Neptune 3 Waste Management System K160693Neptune E-SEP Smoke Evacuation Pencil

View all 43 devices →

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

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.

↑