Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222168

FEI Number

1222168

Entity Name

TeleMed Systems

City/State/Country

Northborough, MA, US

Establishment Address

44 Bearfoot Rd Ste 200, Northborough, MA 01532, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SHENT USA, INC. (Owner Number: 10078923)

Owner / Operator Contact Address

8 Kane Industrial Drive, Hudson, MA 01749, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Guide Wires, "J" & Straight Duralon Occl. Balloon, 2 lumen Retrieval Devices Duralon Occl. Balloon, 3 lumen Sure-flex Balloon Dilatation Cath. Heiss-Device, Endoscopic Scissors Bronchial Cytology Brush ERCP Cannulas Transbronchial Needle Polypectomy Snares DISPOSABLE GRASPING FORCEPS Hot Biopsy Forceps G.I. Cytology Brush Carr-locke, forceps, retriever Biopsy Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-11-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2020-11-10
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2020-11-10
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-11-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-11-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2020-11-10
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-11-10
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2020-11-10
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2020-11-10
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2020-11-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2020-11-10
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-11-10
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-11-10
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2020-11-10
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2020-11-10
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2020-11-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2020-11-10
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2020-11-10
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-11-10
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-11-10

Official Correspondent

Hanbin Suh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SHENT USA, 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
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K923489	Cox Medical Ent., Inc.	COX DISPOSABLE RETRIEVAL DEVICES	1992-09-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222168. Last updated year: 2026. Please use registration number 1222168 when referencing this establishment in official correspondence.