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FDA 510(k)

SB Soft Hood - Straight type, SB Soft Hood - Undercut type

K-Number: K173004 · 2018-05-08

ApplicantSumitomo Bakelite Co., Ltd.
Decision Date2018-05-08
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is a medical device manufactured by Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2018-05-08 under approval number K173004. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is a medical device that received FDA 510(k) clearance on 2018-05-08. It is manufactured by Sumitomo Bakelite Co., Ltd.. The 510(k) number is K173004.

When was SB Soft Hood - Straight type, SB Soft Hood - Undercut type approved by the FDA?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type received FDA 510(k) clearance on 2018-05-08, under approval number K173004.

What company makes SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is manufactured by Sumitomo Bakelite Co., Ltd..

What is the FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

The FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type is FDS.

Other Devices by Sumitomo Bakelite Co., Ltd.

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long K182520Flexible Overtube K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

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K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc. K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation K180911Visura Technologies TEECAD SystemVisura Technologies, LLC

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.

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