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FDA 510(k)

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

K-Number: K083499 · 2009-05-08

ApplicantColoplast A/S
Decision Date2009-05-08
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K083499. 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 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS?

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Coloplast A/S. The 510(k) number is K083499.

When did EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS receive FDA 510(k) clearance?

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS received FDA 510(k) clearance on 2009-05-08, under 510(k) number K083499.

Who is the listed applicant for EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS?

The FDA product code for EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS 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.

K122459PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEMBoston Scientific CorporationK121612ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONAmerican Medical SystemsK112842AMS ELEVATE PCAmerican Medical Systems, Inc.K103426LITE PELVIC FLOOR REPAIR KITSBoston Scientific CorpK112386EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMColoplast Corp.K102815SURELIFT PROLAPSE SYSTEMNeomedic International

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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