Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013960851

FEI Number

3013960851

Entity Name

RIGICON AS

City/State/Country

Bakirkoy Istanbul, TR

Establishment Address

Yesilkoy SB Mah. K Blok No:6, Bakirkoy Istanbul 34149, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rigicon AS (Owner Number: 10055846)

Owner / Operator Contact Address

ERTURK SOK. NO:1, BEYKOZ, TR-34 34810, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RIGICON DILATOM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAG	Prosthesis, Urethral Sphincter	Unknown	Class 3	N/A	2019-08-08
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-02-05
FAE	Prosthesis, Penile	Gastroenterology, Urology	Class 2	876.3630	2019-05-09
FAF	Prosthesis, Testicular	Gastroenterology, Urology	Class 3	876.3750	2017-10-12
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2024-06-11
FAE	Prosthesis, Penile	Gastroenterology, Urology	Class 2	876.3630	2017-10-12

Official Correspondent

Savaskan Karaoglu

US Agent Details

George Yalin Business: Rigicon,INC. Email: operations@rigicon.com Phone: (888) 2029790

Related Public Records

Same Entity

Rigicon AS

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K900371	Mentor Corp.	MENTOR MODIFIED MALLEABLE PENILE PROSTHESES	1990-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3013987875	RIGICON, INC.	Ronkonkoma, NY, US
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013960851. Last updated year: 2026. Please use registration number 3013960851 when referencing this establishment in official correspondence.