Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020746799

FEI Number

3020746799

Entity Name

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

suzhou Jiangsu, CN

Establishment Address

No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA, suzhou Jiangsu 215000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SCIVITA MEDICAL TECHNOLOGY CO., LTD. (Owner Number: 10082577)

Owner / Operator Contact Address

No. 2, Qingqiu Street, Suzhou Industrial Park,215000 Suzhou, Jiangsu Prov., P.R.CHINA, suzhou, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sample Container Bronchus Sampler 4K UHD Camera System Full HD Enodscopic Image Processor Single-use Biopsy Forceps Single-use Extraction Baskets 4K UHD Laparoscope Broncho Videoscope System LED Light Source Broncho Videoscope System Endoscopic Image Processor Brocho Videoscope System Single-use Broncho Videoscope Full HD Visualization Endoscopic Image Processor 3D Visualization System Scivita 4KINSIGHT ICG imaging system Single-use Extraction Baskets Single-use Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2024-09-06
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2021-08-17
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2021-08-17
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2021-08-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-08-17
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-08-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-08-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-12-03
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2023-05-19
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2023-05-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-08-17
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2021-08-17
NMH	Laparoscope And Accessories, Gynecologic, Reprocessed	Obstetrics/Gynecology	Class 2	884.1720	2021-08-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-12-03
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2021-11-30
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-08-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-04-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-08-17
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-05-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-05-17
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2024-12-03
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-05-19

Official Correspondent

Wu Ruqin

US Agent Details

Alexander Hubbard Email: Alexander@scivitamedical.com Phone: (713) 5766675

Related Public Records

Same Entity

SCIVITA MEDICAL TECHNOLOGY 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
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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

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-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020746799. Last updated year: 2026. Please use registration number 3020746799 when referencing this establishment in official correspondence.