SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.

FDA Device Registration & Listing · Cixi Zhejiang, CN · Registration 3015540957

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015540957
FEI Number
3015540957
Entity Name
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
City/State/Country
Cixi Zhejiang, CN
Establishment Address
No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, Cixi Zhejiang 315301, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Owner Number: 10060870)
Owner / Operator Contact Address
No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, Cixi, CN-ZJ 315301, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K183153
PMA Number
N/A

All Registered Proprietary Names

Electroporation System (N3000) Gas Insufflator Video Endoscopy System, 3D Video Endoscopy System Energy Generator, Model: ES300, ES200, ES100 Electrosurgical mode of Ultrosonic Surgical & Eletrosurgical Generator, Model: SC300ES, SC200ES, SC100ES Ultrasonic Surgical mode of Ultrasonic Surgical & Electrosurgical Generator, Model: SC300ES, SC200ES, SC100ES, SC200 Ultrasonic Scalpel System, Model: SC100E Microwave Ablation System, model: M150E

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OAB Low Energy Direct Current Thermal Ablation System General, Plastic Surgery Class 2 878.4400 2025-09-25
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-10-24
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2021-12-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-12-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-12-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-08-03
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-08-03
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2019-12-10

Official Correspondent

Guofang Ma

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K981334 Richard Wolf Medical Instruments Corp. LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) 1998-09-10
K936071 Smith & Nephew Dyonics, Inc. SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE 1994-08-19
K953574 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER 1995-09-29
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K914997 Conmedcorp ASP-IRRATOR 1992-01-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

Similar Registrations

Registration Number Establishment Name Location
2244478 LYNX Medical NJ Franklin, NJ, US
1319639 Sterigenics U.S., LLC Queensbury, NY, US
9611854 IGEA SPA Carpi (MO) Modena, IT
1000523114 AngioDynamics, Inc. Marlborough, MA, US
3017892510 ANGIODYNAMICS, INC Glens Falls, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015540957. Last updated year: 2026. Please use registration number 3015540957 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.