FDA 510(k)

iSR'obot Biopsy Kit

K-Number: K163502 · 2017-05-16

Decision Date2017-05-16

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

iSR'obot Biopsy Kit is a medical device manufactured by Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2017-05-16 under approval number K163502. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSR'obot Biopsy Kit?

iSR'obot Biopsy Kit is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Biobot Surgical Pte., Ltd.. The 510(k) number is K163502.

When was iSR'obot Biopsy Kit approved by the FDA?

iSR'obot Biopsy Kit received FDA 510(k) clearance on 2017-05-16, under approval number K163502.

What company makes iSR'obot Biopsy Kit?

iSR'obot Biopsy Kit is manufactured by Biobot Surgical Pte., Ltd..

What is the FDA product code for iSR'obot Biopsy Kit?

The FDA product code for iSR'obot Biopsy Kit is ITX.

Other Devices by Biobot Surgical Pte., Ltd.

K161109iSR'obot MRI-US Fusion K213411iSRobot Mona Lisa 2.0 K203659iSR'obot Mona Lisa 1.0 K232320iSR`obot Mona Lisa 2.0

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.