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FDA 510(k)

Single Use Hot Biopsy Forceps FD-231

K-Number: K173495 · 2018-11-30

ApplicantOlympus Medical Systems Corp.
Decision Date2018-11-30
Product CodeQEC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Hot Biopsy Forceps FD-231 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 2018-11-30 under 510(k) number K173495. The device is classified under product code QEC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Hot Biopsy Forceps FD-231?

Single Use Hot Biopsy Forceps FD-231 is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K173495.

When did Single Use Hot Biopsy Forceps FD-231 receive FDA 510(k) clearance?

Single Use Hot Biopsy Forceps FD-231 received FDA 510(k) clearance on 2018-11-30, under 510(k) number K173495.

Who is the listed applicant for Single Use Hot Biopsy Forceps FD-231?

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 Single Use Hot Biopsy Forceps FD-231?

The FDA product code for Single Use Hot Biopsy Forceps FD-231 is QEC.

Related Clinical Trials

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.

NCT07726784Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural EffusionNOT_YET_RECRUITING

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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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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