Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PERMATAPE

K-Number: K162247 · 2016-12-15

ApplicantMedos International SARL
Decision Date2016-12-15
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERMATAPE is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2016-12-15 under approval number K162247. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMATAPE?

PERMATAPE is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Medos International SARL. The 510(k) number is K162247.

When was PERMATAPE approved by the FDA?

PERMATAPE received FDA 510(k) clearance on 2016-12-15, under approval number K162247.

What company makes PERMATAPE?

PERMATAPE is manufactured by Medos International SARL.

What is the FDA product code for PERMATAPE?

The FDA product code for PERMATAPE is GAT.

Other Devices by Medos International SARL

K162327COUGAR® LS Lateral Cage System and COUGAR® System K162912VIPER PRIME™ additions to the VIPER® System K163106CODMAN Integrated Bipolar Cord and Tubing Set K161638SPEEDTRAP Graft Preparation System K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps K160804INTRAFIX(TM) Advance Tibial Fastener System

View all 73 devices →

Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEELTeleflexmedical, Inc.

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.

↑