Uroplasty, Inc.

FDA Regulatory Profile

Uroplasty, Inc. has 0 FDA recalls, 4 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 24, 2020 · NAI
Latest 510(k)
Aug 3, 2012

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances8Oct 4, 2026Not statedCurrent
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 24, 2020Minnetonka, MNDevicesNo Action Indicated (NAI)3002647932
Nov 1, 2016Minnetonka, MNDevicesNo Action Indicated (NAI)3002647932
Nov 16, 2012Minnetonka, MNDevicesNo Action Indicated (NAI)3002647932
Oct 27, 2008Minnetonka, MNDevicesNo Action Indicated (NAI)3002647932

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K121337UROPLASTY RIGID ENDOSCPIC NEEDLESAug 3, 2012
K101847URGENT PC STIMULATOR; URGENT PC LEAD SETOct 21, 2010
K091391UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518Jun 30, 2009
K071822URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12Aug 20, 2007
K061333URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12Jul 3, 2006
K052175I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000Oct 17, 2005
K052025URGENT PC NEUROMODULATION SYSTEMOct 17, 2005
K051905UROPLASTY RIGID ENDOSCOPIC NEEDLEAug 29, 2005