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FDA 510(k)

Single Use Balloon Dilator V (with knife)

K-Number: K193039 · 2019-12-17

ApplicantOlympus Medical Systems Corp.
Decision Date2019-12-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Balloon Dilator V (with knife) is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-12-17 under approval number K193039. 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 Balloon Dilator V (with knife)?

Single Use Balloon Dilator V (with knife) is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K193039.

When was Single Use Balloon Dilator V (with knife) approved by the FDA?

Single Use Balloon Dilator V (with knife) received FDA 510(k) clearance on 2019-12-17, under approval number K193039.

What company makes Single Use Balloon Dilator V (with knife)?

Single Use Balloon Dilator V (with knife) is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Balloon Dilator V (with knife)?

The FDA product code for Single Use Balloon Dilator V (with knife) is KNS.

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Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

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Related Devices (Code: KNS)

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.

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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