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

FDA 510(k)

Filbloc

K-Number: K150553 · 2016-05-19

ApplicantAssut Europe
Decision Date2016-05-19
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Filbloc is the device name listed in this FDA 510(k) record. The listed applicant is Assut Europe. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K150553. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Filbloc?

Filbloc is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Assut Europe. The 510(k) number is K150553.

When did Filbloc receive FDA 510(k) clearance?

Filbloc received FDA 510(k) clearance on 2016-05-19, under 510(k) number K150553.

Who is the listed applicant for Filbloc?

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

What is the FDA product code for Filbloc?

The FDA product code for Filbloc is NEW.

Related Devices (Code: NEW)

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.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.

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.

↑