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FDA 510(k)

CHOLEDOCHOSCOPE

K-Number: K915681 · 1992-01-30

ApplicantApplied Laparoscopy
Decision Date1992-01-30
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHOLEDOCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Laparoscopy. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915681. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLEDOCHOSCOPE?

CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Applied Laparoscopy. The 510(k) number is K915681.

When did CHOLEDOCHOSCOPE receive FDA 510(k) clearance?

CHOLEDOCHOSCOPE received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915681.

Who is the listed applicant for CHOLEDOCHOSCOPE?

The FDA 510(k) record lists Applied Laparoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLEDOCHOSCOPE?

The FDA product code for CHOLEDOCHOSCOPE is FBN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Applied Laparoscopy 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.

K920224DOSCOPE AND ACESSORIES

Related Devices (Code: FBN)

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.

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLCK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development 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.

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