POLYGON MEDICAL, INC.

FDA Device Registration & Listing · Manalapan, NJ, US · Registration 3014407293

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
3014407293
FEI Number
3014407293
Entity Name
POLYGON MEDICAL, INC.
City/State/Country
Manalapan, NJ, US
Establishment Address
19 Ashlynn Ct, Manalapan, NJ 07726, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Polygon Medical, Inc. (Owner Number: 10056693)
Owner / Operator Contact Address
19 Ashlynn Court, Manalapan, NJ 07726, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182675
PMA Number
N/A

All Registered Proprietary Names

Polygon Resection Device

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 2019-01-29

Official Correspondent

Ronald Adams

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Polygon Medical, 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
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16

Similar Registrations

Registration Number Establishment Name Location
3028536560 ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD Hangzhou Zhejiang, CN
3015972753 STERISERVICE SP. Z O.O. Czestochowa Slaskie, PL
9611612 PAJUNK GMBH MEDIZINTECHNOLOGIE GEISINGEN Baden-Wurttemberg, DE
3033902430 OMEC THAI CO.,LTD. Bang Bo District Samut Prakan, TH
3014342096 KARL STORZ SE & CO KG TUTTLINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014407293. Last updated year: 2026. Please use registration number 3014407293 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.