Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1052728

FEI Number

1000113735

Entity Name

INVOTEC INTERNATIONAL, INC.

City/State/Country

Jacksonville, FL, US

Establishment Address

6833 PHILLIPS INDUSTRIAL BLVD., Jacksonville, FL 32256, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

INVOTEC INTERNATIONAL, INC. (Owner Number: 9000512)

Owner / Operator Contact Address

6833 PHILLIPS INDUSTRIAL BLVD., --, Jacksonville, FL 32256, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K003567

PMA Number

N/A

All Registered Proprietary Names

Blades Gelita-Spon Absorable Gelatin Sponge Hemostat Clearview Endoscope Cover Invotec Internal Nasal Splint AntiFog Invotec Septal Button Invotec Ventilation Tubes Invotec Tracheal T-Tube NASAL SICKEL KNIFE Invotec Ear Hook Invotec Tonsil Cannula Invotec ENT Blades Invotec Laryngeal Electrode Audio Technologies Middle Ear Implants Total and Partials NASAL PUNCH Spiggle and Theis Ossicular Replacement NOSE BUR#EAR AND THROAT Invotec Mouth Guard PVA Nasal Tampons PVA Nasal Packs Mediplast Suction Tube SWISS THERAPY Invotec Phenol Applicator Kit POST-STAT QUICK-PACIC ULTRA-STAT SerenoCem Otologic Bone Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2014-10-15
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2011-01-19
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2011-01-19
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2009-01-12
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	1992-10-09
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2011-01-19
LFB	Button, Nasal Septal	Unknown	Class U	N/A	2008-02-15
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-02-15
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-02-15
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	1992-10-09
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2015-03-05
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2015-03-05
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2021-06-24
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-11-13
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2022-06-29
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2022-06-29
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	1992-10-09
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-02-15
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-02-15
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2003-08-05
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2017-01-25
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-03-12
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2008-02-18
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	1992-10-09
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2024-10-09
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	1992-10-09
NEA	Cement, Ear, Nose And Throat	Dental	Class 2	872.3275	2011-01-19

Official Correspondent

JEFFREY AULL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INVOTEC INTERNATIONAL, 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
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09
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
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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1052728. Last updated year: 2026. Please use registration number 1052728 when referencing this establishment in official correspondence.