Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008912461

FEI Number

3008912461

Entity Name

SMENG CO.,LTD.

City/State/Country

Busan, KR

Establishment Address

46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan 46910, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SMENG co.,ltd. (Owner Number: 10044758)

Owner / Operator Contact Address

46,Nakdong-daero 1302beon-gil, Sasang-gu, Busan, KR-26 46910, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SM ENG CO.,LTD, SM ENG CO.,LTD, SM ENG CO.,LTD, SM ENG CO.,LTD, SM ENG CO.,LTD, SM ENG CO.,LTD, SM ENG CO.,LTD, Ez-Tcon Mono, Ez-Tcon Needle SM ENG CO.,LTD, SM ENG CO.,LTD, Ez-Tcon Surgi, Ez-Tcon Needle SM ENG CO.,LTD, SM ENG CO.,LTD,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2017-03-14
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2017-03-14
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2014-09-02
HDH	Needle, Cerclage, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2014-09-02
HAS	Needle, Neurosurgical Suture	Neurology	Class 1	882.4650	2014-09-02
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2017-02-13
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2014-09-02
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2018-07-16
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2018-07-16
DZM	Needle, Dental	Dental	Class 1	872.4730	2014-09-02
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-07-08
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-06-05
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-05-14

Official Correspondent

Gilsoo Lee

US Agent Details

Vera Au Business: Applied Dental, Incorporated Email: vera@AD-Surgical.com Phone: (408) 7248832

Related Public Records

Same Entity

SMENG co.,ltd.

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
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008912461. Last updated year: 2026. Please use registration number 3008912461 when referencing this establishment in official correspondence.