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FDA 510(k)

Polygon Resection Device

K-Number: K182675 · 2019-01-04

ApplicantPolygon Medical, Inc.
Decision Date2019-01-04
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Polygon Resection Device is the device name listed in this FDA 510(k) record. The listed applicant is Polygon Medical, Inc.. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K182675. 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 Polygon Resection Device?

Polygon Resection Device is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Polygon Medical, Inc.. The 510(k) number is K182675.

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

Polygon Resection Device received FDA 510(k) clearance on 2019-01-04, under 510(k) number K182675.

Who is the listed applicant for Polygon Resection Device?

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

What is the FDA product code for Polygon Resection Device?

The FDA product code for Polygon Resection Device is HIH.

Related Devices (Code: HIH)

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.

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 EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

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.

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