Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007713076

FEI Number

3007713076

Entity Name

EXXELIA MICROPEN

City/State/Country

Honeoye Falls, NY, US

Establishment Address

93 Papermill St, Honeoye Falls, NY 14472, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Exxelia Micropen (Owner Number: 10042759)

Owner / Operator Contact Address

93 Paper Mill Street, Honeoye Falls, NY 14472, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2014-12-05
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2014-12-05
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2014-12-05
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-12-05
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-12-05

Official Correspondent

Vivek Sharma

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exxelia Micropen

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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Similar Registrations

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3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
1420054	LSL HEALTHCARE	Niles, IL, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007713076. Last updated year: 2026. Please use registration number 3007713076 when referencing this establishment in official correspondence.