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)

UROPLASTY RIGID ENDOSCPIC NEEDLES

K-Number: K121337 · 2012-08-03

ApplicantUroplasty, Inc.
Decision Date2012-08-03
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROPLASTY RIGID ENDOSCPIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Uroplasty, Inc.. It received FDA 510(k) clearance on 2012-08-03 under 510(k) number K121337. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROPLASTY RIGID ENDOSCPIC NEEDLES?

UROPLASTY RIGID ENDOSCPIC NEEDLES is a medical device that received FDA 510(k) clearance on 2012-08-03. The listed applicant is Uroplasty, Inc.. The 510(k) number is K121337.

When did UROPLASTY RIGID ENDOSCPIC NEEDLES receive FDA 510(k) clearance?

UROPLASTY RIGID ENDOSCPIC NEEDLES received FDA 510(k) clearance on 2012-08-03, under 510(k) number K121337.

Who is the listed applicant for UROPLASTY RIGID ENDOSCPIC NEEDLES?

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

What is the FDA product code for UROPLASTY RIGID ENDOSCPIC NEEDLES?

The FDA product code for UROPLASTY RIGID ENDOSCPIC NEEDLES is FBK.

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 Uroplasty, 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.

K101847URGENT PC STIMULATOR; URGENT PC LEAD SETK091391UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518K071822URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12K061333URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12K052025URGENT PC NEUROMODULATION SYSTEMK052175I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000

View all 8 devices →

Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., 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.

↑