Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Single Use Hot Biopsy Forceps FD-231

K-Number: K171916 · 2017-10-13

ApplicantOlympus Medical Systems Corp.
Decision Date2017-10-13
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Hot Biopsy Forceps FD-231 is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2017-10-13 under approval number K171916. The device is classified under product code KGE. 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 2017-10-13. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K171916.

When was Single Use Hot Biopsy Forceps FD-231 approved by the FDA?

Single Use Hot Biopsy Forceps FD-231 received FDA 510(k) clearance on 2017-10-13, under approval number K171916.

What company makes Single Use Hot Biopsy Forceps FD-231?

Single Use Hot Biopsy Forceps FD-231 is manufactured by Olympus Medical Systems Corp..

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 KGE.

Related Clinical Trials

NCT07376837 Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study RECRUITING NCT06298305 Artificial Intelligence & Prostate Cancer COMPLETED NCT07136324 Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry ACTIVE_NOT_RECRUITING NCT04035642 Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II) RECRUITING NCT06824402 Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients RECRUITING NCT07542041 Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens RECRUITING

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

View all 77 devices →

Related Devices (Code: KGE)

K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC

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.

↑