FDA.reportPublic FDA data

GYNESONICS, INC.

Matched from indexed company URL: Gynesonics, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058756753005875675GYNESONICS, INC.1N2026-01-01200 Cardinal Way #250 REDWOOD CITY CA US 94063
30058756753005875675GYNESONICS, INC.1N2020-04-25600 Chesapeake Drive REDWOOD CITY CA US 94063

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
10817929020005Sonata® Case Kit - Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes650-216-3860customersupport@gynesonics.com
10817929020135Sonata® IUUS Probe Sterile Shipper Kit - Sterilization packaging, single use650-216-3860customersupport@gynesonics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3420451961946932K250705Sonata Transcervical Fibroid Ablation System 2.2KNF2025-04-02
3420451318492505K240503Sonata Transcervical Fibroid Ablation System 2.2KNF2024-07-17
3420451061407327K222304Sonata Transcervical Fibroid Ablation System 2.2KNF2022-11-08
3420451181664826K211535Sonata Transcervical Fibroid Ablation System 2.2KNF2021-06-17
666552044431334K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemKNF2018-08-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNF52025-04-02

PMN#

GUDID#