Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020142503

FEI Number

3020142503

Entity Name

OMEC MEDICAL NV INC

City/State/Country

Reno, NV, US

Establishment Address

5690 Riggins CT, Reno, NV 89502, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OMEC Medical NV Inc. (Owner Number: 10082628)

Owner / Operator Contact Address

5690 Riggins CT, Reno, NV 89502, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPY Bariatric Laparoscope, Autoclavable, 10mm x 0, 45cm SPY Laparoscope, Autoclavable, 5.4 mm x 0, 30cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 30, 45cm SPY Laparoscope, Autoclavable, 5.4 mm x 30, 30cm SPY Laparoscope, Autoclavable, 10mm x 45, 33cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 45, 45cm SPY Laparoscope, Autoclavable, 10mm x 30, 33cm SPY Laparoscope, Autoclavable, 10mm x 0, 33cm SPY Laparoscope, Autoclavable, 5.4 mm x 45, 30cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 30, 45cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 45, 45cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 0, 45cm

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	2024-06-27

Official Correspondent

Anmin Zheng

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OMEC Medical NV Inc.

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.

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 3020142503. Last updated year: 2026. Please use registration number 3020142503 when referencing this establishment in official correspondence.