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FDA 510(k)

URGENT PC STIMULATOR; URGENT PC LEAD SET

K-Number: K101847 · 2010-10-21

ApplicantUroplasty, Inc.
Decision Date2010-10-21
Product CodeNAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URGENT PC STIMULATOR; URGENT PC LEAD SET is the device name listed in this FDA 510(k) record. The listed applicant is Uroplasty, Inc.. It received FDA 510(k) clearance on 2010-10-21 under 510(k) number K101847. 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 STIMULATOR; URGENT PC LEAD SET?

URGENT PC STIMULATOR; URGENT PC LEAD SET is a medical device that received FDA 510(k) clearance on 2010-10-21. The listed applicant is Uroplasty, Inc.. The 510(k) number is K101847.

When did URGENT PC STIMULATOR; URGENT PC LEAD SET receive FDA 510(k) clearance?

URGENT PC STIMULATOR; URGENT PC LEAD SET received FDA 510(k) clearance on 2010-10-21, under 510(k) number K101847.

Who is the listed applicant for URGENT PC STIMULATOR; URGENT PC LEAD SET?

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 STIMULATOR; URGENT PC LEAD SET?

The FDA product code for URGENT PC STIMULATOR; URGENT PC LEAD SET 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.

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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 NEEDLESK091391UROPLASTY 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: 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.K071822URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12Uroplasty, Inc.K061333URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A 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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