FDA 510(k)

GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS

K-Number: K071512 · 2008-05-15

Decision Date2008-05-15

Product CodeOTP

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K071512. 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 GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS?

GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is ETHICON, Inc.. The 510(k) number is K071512.

When did GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS receive FDA 510(k) clearance?

GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS received FDA 510(k) clearance on 2008-05-15, under 510(k) number K071512.

Who is the listed applicant for GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS?

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

What is the FDA product code for GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS?

The FDA product code for GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS is OTP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing ETHICON, Inc. as applicant

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

View all 195 devices →

Related Devices (Code: OTP)

K122459PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEMBoston Scientific Corporation K121612ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONAmerican Medical Systems K112842AMS ELEVATE PCAmerican Medical Systems, Inc.K103426LITE PELVIC FLOOR REPAIR KITSBoston Scientific Corp K112386EXAIR 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.