Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011221476

FEI Number

3011221476

Entity Name

AB MEDICA SAS

City/State/Country

Mery Sur Cher Centre-Val de Loire, FR

Establishment Address

Les Petites Quarterees, Mery Sur Cher Centre-Val de Loire 18100, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ab Medica SAS (Owner Number: 10047343)

Owner / Operator Contact Address

Les Petites Quarterees, Mery Sur Cher, FR-CVL 18100, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140101

PMA Number

N/A

All Registered Proprietary Names

Laparoscope Pneumo Dissector Hook Pneumo Dissector Handle SCALPEL ACCESSORY TOOL AbMedica Laparoscopic Hand Instrument and Trocar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-03-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-06-05
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2019-01-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-08-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

ab Medica SAS

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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
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

Similar Registrations

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1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011221476. Last updated year: 2026. Please use registration number 3011221476 when referencing this establishment in official correspondence.