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

FDA 510(k)

OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)

K-Number: K962387 · 1996-07-31

ApplicantOlympus America, Inc.
Decision Date1996-07-31
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1996-07-31 under 510(k) number K962387. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)?

OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) is a medical device that received FDA 510(k) clearance on 1996-07-31. The listed applicant is Olympus America, Inc.. The 510(k) number is K962387.

When did OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) receive FDA 510(k) clearance?

OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) received FDA 510(k) clearance on 1996-07-31, under 510(k) number K962387.

Who is the listed applicant for OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)?

The FDA product code for OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) is FFL.

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 Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

View all 149 devices →

Related Devices (Code: FFL)

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.

K190492Peralta Stone Removal CatheterCalcula Technologies, Inc.K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion MedicalK102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510Percutaneous Systems, Inc.K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015Percutaneous Systems, Inc.K052048ACCORDIONPercutaneous Systems, IncorporatedK012581REPROCESSED STONE RETRIEVAL BASKETSSterilmed, Inc.

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.

↑