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FDA 510(k)

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

K-Number: K163069 · 2017-01-19

ApplicantOlympus Medical Systems Corp.
Decision Date2017-01-19
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K163069. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM?

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K163069.

When did OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM receive FDA 510(k) clearance?

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM received FDA 510(k) clearance on 2017-01-19, under 510(k) number K163069.

Who is the listed applicant for OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM?

The FDA product code for OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is NEZ.

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Other records listing Olympus Medical Systems Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 112 devices →

Related Devices (Code: NEZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

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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