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FDA 510(k)

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

K-Number: K081710 · 2008-10-15

ApplicantAmerican Medical Systems
Decision Date2008-10-15
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K081710. 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 APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE?

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is American Medical Systems. The 510(k) number is K081710.

When did APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE receive FDA 510(k) clearance?

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE received FDA 510(k) clearance on 2008-10-15, under 510(k) number K081710.

Who is the listed applicant for APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE?

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

What is the FDA product code for APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE?

The FDA product code for APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE is OTP.

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Other records listing American Medical Systems 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.

K131229SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMSK121805AMS LARGE PORE POLYPROPHLENE MESHK121641MINIARC PRO SINGLE-INCISION SLING SYSTEMK121612ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONK120870GREENLIGHT MOXY FIBER OPTICK111118AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

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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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