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FDA 510(k)

I-STOP

K-Number: K051533 · 2005-08-11

ApplicantCl Medical
Decision Date2005-08-11
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I-STOP is the device name listed in this FDA 510(k) record. The listed applicant is Cl Medical. It received FDA 510(k) clearance on 2005-08-11 under 510(k) number K051533. 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?

I-STOP is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Cl Medical. The 510(k) number is K051533.

When did I-STOP receive FDA 510(k) clearance?

I-STOP received FDA 510(k) clearance on 2005-08-11, under 510(k) number K051533.

Who is the listed applicant for I-STOP?

The FDA 510(k) record lists Cl Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-STOP?

The FDA product code for I-STOP is OTN.

Other records listing Cl Medical 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.

K063079I-STOP TRANS OBTURATOR MALE SLING

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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