FDA 510(k)

Resectr Tissue Resection Device

K-Number: K191538 · 2020-01-16

Decision Date2020-01-16

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Resectr Tissue Resection Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K191538. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resectr Tissue Resection Device?

Resectr Tissue Resection Device is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Boston Scientific Corporation. The 510(k) number is K191538.

When did Resectr Tissue Resection Device receive FDA 510(k) clearance?

Resectr Tissue Resection Device received FDA 510(k) clearance on 2020-01-16, under 510(k) number K191538.

Who is the listed applicant for Resectr Tissue Resection Device?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resectr Tissue Resection Device?

The FDA product code for Resectr Tissue Resection Device is HIH.

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Related Devices (Code: HIH)

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker Endoscopy K243382RZ Resectoscope SystemRz Medizintechnik GmbH

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.