FDA 510(k)

OT-1

K-Number: K972781 · 1997-09-19

Decision Date1997-09-19

Product CodeFED

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Prism Therapeutics, LLC. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K972781. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OT-1?

OT-1 is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Prism Therapeutics, LLC. The 510(k) number is K972781.

When did OT-1 receive FDA 510(k) clearance?

OT-1 received FDA 510(k) clearance on 1997-09-19, under 510(k) number K972781.

Who is the listed applicant for OT-1?

The FDA 510(k) record lists Prism Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OT-1?

The FDA product code for OT-1 is FED.

Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.