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FDA 510(k)

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

K-Number: K190772 · 2019-10-10

ApplicantOlympus Medical Systems Corp.
Decision Date2019-10-10
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR 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 2019-10-10 under 510(k) number K190772. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR?

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K190772.

When did SURGICAL MICROSCOPE SYSTEM ORBEYE with IR receive FDA 510(k) clearance?

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR received FDA 510(k) clearance on 2019-10-10, under 510(k) number K190772.

Who is the listed applicant for SURGICAL MICROSCOPE SYSTEM ORBEYE with IR?

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 SURGICAL MICROSCOPE SYSTEM ORBEYE with IR?

The FDA product code for SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is IZI.

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

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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