FDA.reportPublic FDA data

CALDERA MEDICAL SARL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
CALDERA MEDICAL SARL5N2026-01-01Rue du Puits-Godet 20 Neuchatel CH 2000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3522681895915367K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged GuideOTN2020-09-17
3522681196420253K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemPWJ2018-08-10
3522681570053884K173162GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter GuidePWJ2018-06-28
3522681617671921K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System TrocarPWJ2018-07-06
3522681647408384K132054GYNECARE TVT EXACT CONTINENCE SYSTEMOTN2013-08-23
3522681295358633K100936GYNECARE TVT ABBREVO CONTINENCE SYSTEMOTN2010-07-01
3522681189531434K100485GYNECARE TVT EXACT CONTINENCE SYSTEMOTN2010-03-16
3522681498753217K033568GYNECARE TVT OBTURATOR SYSTEMOTN2003-12-08
3522681390516857K012628GYNECARE TENSION-FREE VAGINAL TAPE SYSTEMOTN2001-10-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTN62020-09-17
PWJ32018-08-10