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FDA 510(k)

SURELIFT PROLAPSE SYSTEM

K-Number: K102815 · 2011-07-07

ApplicantNeomedic International
Decision Date2011-07-07
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURELIFT PROLAPSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neomedic International. It received FDA 510(k) clearance on 2011-07-07 under 510(k) number K102815. The device is classified under product code OTP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURELIFT PROLAPSE SYSTEM?

SURELIFT PROLAPSE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-07. The listed applicant is Neomedic International. The 510(k) number is K102815.

When did SURELIFT PROLAPSE SYSTEM receive FDA 510(k) clearance?

SURELIFT PROLAPSE SYSTEM received FDA 510(k) clearance on 2011-07-07, under 510(k) number K102815.

Who is the listed applicant for SURELIFT PROLAPSE SYSTEM?

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

What is the FDA product code for SURELIFT PROLAPSE SYSTEM?

The FDA product code for SURELIFT PROLAPSE SYSTEM is OTP.

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Related Devices (Code: OTP)

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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Official Source

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