Statice SA

FDA Device Registration & Listing · BESANCON Doubs, FR · Registration 3002894438

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
3002894438
FEI Number
3002894438
Entity Name
Statice SA
City/State/Country
BESANCON Doubs, FR
Establishment Address
9, Rue Thomas Edison, BESANCON Doubs 25000, FR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STATICE (Owner Number: 10051928)
Owner / Operator Contact Address
9, Rue Thomas Edison, Besancon, FR-25 25000, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Radio Frequency (RF) Ablation Catheter KeriFlex® MCP and PIP Finger Joint Prostheses

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2018-10-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2024-05-29
KYJ Prosthesis, Finger, Constrained, Polymer Orthopedic Class 2 888.3230 2022-09-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

STATICE
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
K172288 Wilson-Cook Medical Inc./Cook Endoscopy Fusion OMNI Sphincterotome 2018-04-17

Similar Registrations

Registration Number Establishment Name Location
3013526170 Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Changzhou Jiangsu, CN
1000121056 Boston Scientific Corporation Coventry, RI, US
3002807310 Synergy Health Sterilisation UK Ltd Berkshire Reading, GB
1320894 CONMED CORPORATION Utica, NY, US
3014769442 Aomori Olympus Co., Ltd. Hirosaki Site Hirosaki-shi Aomori, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002894438. Last updated year: 2026. Please use registration number 3002894438 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.