Cleared Traditional

K162749 - FUJIFILM Hood Models DH-28GR

K162749 is the FDA 510(k) clearance for FUJIFILM Hood Models DH-28GR by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K162749 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
258d
Days
Class 2
Risk

K162749 is an FDA 510(k) clearance for the FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on June 15, 2017 after a review of 258 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K162749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date June 15, 2017
Days to Decision 258 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 130d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 57
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K162749.
Visura Technologies TEECAD System
K180911 · Visura Technologies, LLC · Jun 2018
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
K173004 · Sumitomo Bakelite Co., Ltd. · May 2018
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
K172916 · Fujifilm Corporation · Mar 2018
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · Fujifilm Medical System U.S.A., Inc. · Mar 2016
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · Fujifilm Medical System U.S.A., Inc. · May 2015
FOREIGN BODY HOOD
K130148 · United States Endoscopy Group, Inc. · Aug 2013