RIGICON, INC.

FDA Device Registration & Listing · Ronkonkoma, NY, US · Registration 3013987875

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
3013987875
FEI Number
3013987875
Entity Name
RIGICON, INC.
City/State/Country
Ronkonkoma, NY, US
Establishment Address
2805 Veterans Highway, Suite 5, Ronkonkoma, NY 11779, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device
Owner / Operator
Rigicon, Inc. (Owner Number: 10055847)
Owner / Operator Contact Address
2805 Veterans Highway, SUITE 5, Ronkonkoma, NY 11779, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Rigicon Surgical Retractor Kit Rigicon Furlow Insertion Tool Rigicon HL Dilator Testi10 Firm Testicular Prosthesis Testi 10 Saline-Filled Testicular Proshesis

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FAE Prosthesis, Penile Gastroenterology, Urology Class 2 876.3630 2019-05-09
FAG Prosthesis, Urethral Sphincter Unknown Class 3 N/A 2019-08-08
GAD Retractor General, Plastic Surgery Class 1 878.4800 2022-06-07
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2020-07-07
FAF Prosthesis, Testicular Gastroenterology, Urology Class 3 876.3750 2017-10-12

Official Correspondent

Ahmet Luleci

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rigicon, 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
K900371 Mentor Corp. MENTOR MODIFIED MALLEABLE PENILE PROSTHESES 1990-11-02
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

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.

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1000121056 Boston Scientific Corporation Coventry, RI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013987875. Last updated year: 2026. Please use registration number 3013987875 when referencing this establishment in official correspondence.
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