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FDA 510(k)

PENTAX Medical Endoscopic Ultrasound System

K-Number: K182004 · 2018-08-21

ApplicantPentax of America, Inc.
Decision Date2018-08-21
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Endoscopic Ultrasound System is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K182004. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Endoscopic Ultrasound System?

PENTAX Medical Endoscopic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Pentax of America, Inc.. The 510(k) number is K182004.

When was PENTAX Medical Endoscopic Ultrasound System approved by the FDA?

PENTAX Medical Endoscopic Ultrasound System received FDA 510(k) clearance on 2018-08-21, under approval number K182004.

What company makes PENTAX Medical Endoscopic Ultrasound System?

PENTAX Medical Endoscopic Ultrasound System is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Endoscopic Ultrasound System?

The FDA product code for PENTAX Medical Endoscopic Ultrasound System is ODG.

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Other Devices by Pentax of America, Inc.

K162151PENTAX Medical ENT Video Imaging System K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

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Related Devices (Code: ODG)

K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerPentax of America, Inc. K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K180731Ultramatrix EUS BalloonUnited States Endoscopy Group, Inc. (Us Endoscopy)

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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