FDA 510(k)

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

K-Number: K182408 · 2019-05-15

Decision Date2019-05-15

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 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 2019-05-15 under 510(k) number K182408. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K182408.

When did Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 receive FDA 510(k) clearance?

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182408.

Who is the listed applicant for Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

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 Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

The FDA product code for Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 is KNS.

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-LB K260580Single 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: KNS)

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

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.