FDA.reportPublic FDA data

510(k) K240763

Device
FirstFit Surgical Kit
Applicant
Freudenberg Medical, LLC
510(k) number
K240763
Product code
EWL
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-18
Date received
2024-03-20
Regulation
874.3730
Classification name
Prosthesis, Laryngeal (Taub)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Oliver Krause-Huckelberry
Address
1110 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EWL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141380PROVOX FREEHANDS FLEXIVOICEAtos Medical AB2014-09-26
K131947PROVOX VEGA PUNCTURE SETAtos Medical AB2013-10-18
K092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical AB2010-10-14
K093258BLOM-SINGER INDWELLING TEP OCCLUDERHelix Medical, LLC2010-03-03
K090455PROVOX VEGA, MODEL 8130-8135Atos Medical AB2009-06-05
K082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLC2008-09-04
K043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134Atos Medical AB2004-11-22
K022125PROVOX FREEHANDS HME, MODEL 7710Atos Medical AB2002-07-30
K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISHelix Medical, Inc.1999-06-25
K974132VOICE MASTER PROSTHESISE. Benson Hood Lab, Inc.1998-02-25
K971244PROVOX 2 VOICE PROSTHESIS SYSTEMAtos Medical AB1997-06-06
K945287INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEHelix Medical, Inc.1994-12-09
K945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEHelix Medical, Inc.1994-12-02
K940638PROVOX(TM) VOICE PROSTHESISAtos Medical AB1994-06-22
K932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESHelix Medical, Inc.1994-04-15