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FDA 510(k)

I-STOP TRANS OBTURATOR MALE SLING

K-Number: K063079 · 2006-11-07

ApplicantCl Medical
Decision Date2006-11-07
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I-STOP TRANS OBTURATOR MALE SLING is the device name listed in this FDA 510(k) record. The listed applicant is Cl Medical. It received FDA 510(k) clearance on 2006-11-07 under 510(k) number K063079. The device is classified under product code OTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STOP TRANS OBTURATOR MALE SLING?

I-STOP TRANS OBTURATOR MALE SLING is a medical device that received FDA 510(k) clearance on 2006-11-07. The listed applicant is Cl Medical. The 510(k) number is K063079.

When did I-STOP TRANS OBTURATOR MALE SLING receive FDA 510(k) clearance?

I-STOP TRANS OBTURATOR MALE SLING received FDA 510(k) clearance on 2006-11-07, under 510(k) number K063079.

Who is the listed applicant for I-STOP TRANS OBTURATOR MALE SLING?

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 TRANS OBTURATOR MALE SLING?

The FDA product code for I-STOP TRANS OBTURATOR MALE SLING is OTM.

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 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.

K051533I-STOP

Related Devices (Code: OTM)

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.

K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific CorporationK231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplastK211847AdVance XP Male Sling SystemBoston Scientific CorporationK182169AdVance XP Male SlingBoston Scientific CorporationK113496VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITColoplast A/SK111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KITColoplast A/S

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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