Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018064853

FEI Number

3018064853

Entity Name

CPT SUTURES CO., LTD.

City/State/Country

Ho Chi Minh City, VN

Establishment Address

8 Dao Tri Street, Phu Thuan Ward, Ho Chi Minh City 70000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CPT SUTURES CO., LTD. (Owner Number: 10080643)

Owner / Operator Contact Address

8 Dao Tri Street, Phu Thuan Ward, Ho Chi Minh, VN-SG 700000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170166

PMA Number

N/A

All Registered Proprietary Names

CARESORB® - Polyglactin 910; CARESORB® RAPID (fast absorbing) TEKSYN® PGA - Polyglycolic Acid (PGA); Rapid, Synthetic Absorbable Suture TEKSYN® 910 - Polyglactin 910 (PGLA); Rapid (fast absorbing) CARESYN® - Polyglycolic Acid; CARESYN® RAPID, Synthetic Absorbable Suture

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2021-02-17

Official Correspondent

Khoa Do

US Agent Details

Edwin Lindsay Business: RAF SOLUTIONS INC Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

CPT SUTURES 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
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-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.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - 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.

Similar Registrations

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1221934	DePuy Mitek, Inc.	RAYNHAM, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018064853. Last updated year: 2026. Please use registration number 3018064853 when referencing this establishment in official correspondence.