FDA 510(k)

Flexible Overtube

K-Number: K182520 · 2019-05-15

Decision Date2019-05-15

Product CodeFED

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Flexible Overtube is a medical device manufactured by Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2019-05-15 under approval number K182520. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Overtube?

Flexible Overtube is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by Sumitomo Bakelite Co., Ltd.. The 510(k) number is K182520.

When was Flexible Overtube approved by the FDA?

Flexible Overtube received FDA 510(k) clearance on 2019-05-15, under approval number K182520.

What company makes Flexible Overtube?

Flexible Overtube is manufactured by Sumitomo Bakelite Co., Ltd..

What is the FDA product code for Flexible Overtube?

The FDA product code for Flexible Overtube is FED.

Other Devices by Sumitomo Bakelite Co., Ltd.

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

Related Devices (Code: FED)

K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. K160846AmplifEYEMedivators, Inc. K160861Proxis Ureteral Access SheathC.R. Bard, Inc. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated

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.