FDA 510(k)

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014

Numéro K : K220549 · 2023-03-07

Date de décision2023-03-07

Code produitNEW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corporation. It received FDA 510(k) clearance on 2023-03-07 under 510(k) number K220549. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014?

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 is a medical device that received FDA 510(k) clearance on 2023-03-07. The listed applicant is Hans Biomed Corporation. The 510(k) number is K220549.

When did MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 receive FDA 510(k) clearance?

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 received FDA 510(k) clearance on 2023-03-07, under 510(k) number K220549.

Who is the listed applicant for MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014?

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

What is the FDA product code for MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014?

The FDA product code for MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 is NEW.

Essais cliniques associés

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Autres dossiers indiquant Hans Biomed Corporation en tant que demandeur

K254238MINT MONO Sutures K192423MINT Product Family K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

Dispositifs connexes (Code : NEW)

K254238MINT MONO SuturesHans Biomed Corporation K253879MONOFIX PDOSamyang Holdings Corporation K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC K252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.

Source officielle

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