FDA.reportPublic FDA data

AXORA MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30432362813043236281AXORA MEDICAL, INC.1N2026-01-011000 Hamlin Ct Sunnyvale CA US 94089

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850083954154Resectr Resection Device 5FR (1.65 mm) - (1) Resectr Tissue Resection Device 5FR (1.65 mm) (1) Vacuum Tube Adapter855-646-7874customerservice@axoramedical.com
00850083954161Resectr Resection Device 9FR (3.0 mm) - (1) Resectr Tissue Resection Device 9FR (3.0 mm) (1) Vacuum Tube Adapter855-646-7874customerservice@axoramedical.com
00850083954352HERizon RD5 Resecting Device - (1) HERizon RD5 Resecting Device (Battery Powered)855-646-7874customerservice@axoramedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3482221433668362P140013MINERVA ENDOMETRIAL ABLATION SYSTEMMNB2015-07-27
3482221621698799P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEMMNB2001-04-20
3482221824192576K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH2026-08-18
3482221889971502K233710Symphion Operative Hysteroscopy SystemPGT2024-01-17
3482222046005759K191538Resectr Tissue Resection DeviceHIH2020-01-16
3482221078289833K160751Symphion Endoscope and Symphion Cervical SheathHIH2016-06-14
3482221215982655K141848IOGYN SYSTEMPGT2014-08-29
3482221029437677
3482221531517256
3482221639349762

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIH32026-08-18
PGT22024-01-17
MNB22015-07-27

GUDID#