LiNA Medical AG

FDA Device Registration & Listing · Root D4 Luzern, CH · Registration 3008693678

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
3008693678
FEI Number
3008693678
Entity Name
LiNA Medical AG
City/State/Country
Root D4 Luzern, CH
Establishment Address
Platz 3, Root D4 Luzern 6039, CH
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
LiNA Medical AG (Owner Number: 10033967)
Owner / Operator Contact Address
Platz 3, Root D4, CH-LU 6039, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hook Forceps Various Hook Forseps (CYV-100-5; CYV-101-5) LiNA CystoVu™ HD (SCP-100-1) LiNA ScopeVu™ LiNA CystoVu™ HD Grasper (CYV-GRA-5) 45-TV LiNA McCartney tube Transvaginal tube 35-TV LiNA McCartney tube Transvaginal tube LiNA CystoVu™ HD Biopsy Forceps (CYV-FCP-5)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-01-26
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2010-10-22
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-08-24
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2026-03-30
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-09-17
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2025-04-09
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2010-11-05
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2025-04-09
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2018-04-09
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2013-10-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-10-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-02-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-01-18
HTD Forceps General, Plastic Surgery Class 1 878.4800 2020-09-07
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-09-07
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-09-07
PXU Fluid Drainage Tray General, Plastic Surgery Class 1 878.4200 2020-09-07

Official Correspondent

Anna Michalska

US Agent Details

Nadege Boursiqout Business: LiNA Medical INC Email: nadege@linamed.com Phone: (770) 2186801

Related Public Records

Same Entity

LiNA Medical AG
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
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16
K950499 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS 1995-06-16
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008693678. Last updated year: 2026. Please use registration number 3008693678 when referencing this establishment in official correspondence.
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