Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040573

FEI Number

6119

Entity Name

AILEE CO., LTD.

City/State/Country

BUSAN, KR

Establishment Address

28, GAYA-DAERO 196BEON-GIL, SASANG-GU, BUSAN 47021, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AILEE CO., LTD. (Owner Number: 8040573)

Owner / Operator Contact Address

28, GAYA-DAERO 196BEON-GIL, SASANG-GU, BUSAN, KR-26 47021, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCALPEL MINI SCALPEL SUTURE NEEDLE SCALPEL BLADE SCALPEL HANDLE

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	1994-12-14
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	1994-12-14
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1994-12-14
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1994-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Kathy Dassler Business: SPECTRA MEDICAL DEVICES, LLC Email: kdassler@spectramedical.com Phone: (978) 6570889

Related Public Records

Same Entity

AILEE CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
1052728	INVOTEC INTERNATIONAL, INC.	Jacksonville, FL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3005675811	QSUM BIOPSY DISPOSABLES LLC	Pequot Lakes, MN, US
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3004050971	VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.	Dong Guan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040573. Last updated year: 2026. Please use registration number 8040573 when referencing this establishment in official correspondence.