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FDA 510(k)

UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518

K-Number: K091391 · 2009-06-30

ApplicantUroplasty, Inc.
Decision Date2009-06-30
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 is the device name listed in this FDA 510(k) record. The listed applicant is Uroplasty, Inc.. It received FDA 510(k) clearance on 2009-06-30 under 510(k) number K091391. 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 ENDOSCOPIC NEEDLE, MRN-518?

UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 is a medical device that received FDA 510(k) clearance on 2009-06-30. The listed applicant is Uroplasty, Inc.. The 510(k) number is K091391.

When did UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 receive FDA 510(k) clearance?

UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 received FDA 510(k) clearance on 2009-06-30, under 510(k) number K091391.

Who is the listed applicant for UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518?

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 ENDOSCOPIC NEEDLE, MRN-518?

The FDA product code for UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 is FBK.

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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.

K121337UROPLASTY RIGID ENDOSCPIC NEEDLESK101847URGENT PC STIMULATOR; URGENT PC LEAD SETK071822URGENT 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

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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.

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