FDA 510(k)

HSW Resection Instruments

K-Number: K173070 · 2018-06-08

Decision Date2018-06-08

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HSW Resection Instruments is a medical device manufactured by Henke-Sass, Wolf GmbH. It received FDA 510(k) clearance on 2018-06-08 under approval number K173070. 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 HSW Resection Instruments?

HSW Resection Instruments is a medical device that received FDA 510(k) clearance on 2018-06-08. It is manufactured by Henke-Sass, Wolf GmbH. The 510(k) number is K173070.

When was HSW Resection Instruments approved by the FDA?

HSW Resection Instruments received FDA 510(k) clearance on 2018-06-08, under approval number K173070.

What company makes HSW Resection Instruments?

HSW Resection Instruments is manufactured by Henke-Sass, Wolf GmbH.

What is the FDA product code for HSW Resection Instruments?

The FDA product code for HSW Resection Instruments is HIH.

Other Devices by Henke-Sass, Wolf GmbH

K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

Related Devices (Code: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, 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.