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FDA 510(k)

I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000

K-Number: K052175 · 2005-10-17

ApplicantUroplasty, Inc.
Decision Date2005-10-17
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Uroplasty, Inc.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052175. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000?

I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Uroplasty, Inc.. The 510(k) number is K052175.

When did I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 receive FDA 510(k) clearance?

I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052175.

Who is the listed applicant for I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000?

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 I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000?

The FDA product code for I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 is OTN.

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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 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 SYSTEM

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Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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