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FDA 510(k)

PINNACLE PELVIC FLOOR REPAIR KITS

K-Number: K071957 · 2007-11-08

ApplicantBoston Scientific Corp
Decision Date2007-11-08
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PINNACLE PELVIC FLOOR REPAIR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2007-11-08 under 510(k) number K071957. 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 PINNACLE PELVIC FLOOR REPAIR KITS?

PINNACLE PELVIC FLOOR REPAIR KITS is a medical device that received FDA 510(k) clearance on 2007-11-08. The listed applicant is Boston Scientific Corp. The 510(k) number is K071957.

When did PINNACLE PELVIC FLOOR REPAIR KITS receive FDA 510(k) clearance?

PINNACLE PELVIC FLOOR REPAIR KITS received FDA 510(k) clearance on 2007-11-08, under 510(k) number K071957.

Who is the listed applicant for PINNACLE PELVIC FLOOR REPAIR KITS?

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

What is the FDA product code for PINNACLE PELVIC FLOOR REPAIR KITS?

The FDA product code for PINNACLE PELVIC FLOOR REPAIR KITS 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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