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FDA 510(k)

URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12

K-Number: K061333 · 2006-07-03

ApplicantUroplasty, Inc.
Decision Date2006-07-03
Product CodeNAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 is the device name listed in this FDA 510(k) record. The listed applicant is Uroplasty, Inc.. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061333. The device is classified under product code NAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12?

URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Uroplasty, Inc.. The 510(k) number is K061333.

When did URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 receive FDA 510(k) clearance?

URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061333.

Who is the listed applicant for URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12?

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 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12?

The FDA product code for URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 is NAM.

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.

K121337UROPLASTY RIGID ENDOSCPIC NEEDLESK101847URGENT PC STIMULATOR; URGENT PC LEAD SETK091391UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518K071822URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 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: NAM)

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.

K220454Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile ApplicationAvation Medical, Inc.K192731ZIDA Wearable Neuromodulation SystemExodus InnovationsK132561NURO NEUROMODULATION SYSTEMAdvanced Uro-Solutions, Inc.K101847URGENT PC STIMULATOR; URGENT PC LEAD SETUroplasty, Inc.K071822URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12Uroplasty, Inc.K052025URGENT PC NEUROMODULATION SYSTEMUroplasty, 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.

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