Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611459

FEI Number

3002807993

Entity Name

RESORBA Medical GmbH

City/State/Country

NUERNBERG Bavaria, DE

Establishment Address

AM FLACHMOOR 16, NUERNBERG Bavaria D-90475, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADVANCED MEDICAL SOLUTIONS GROUP PLC (Owner Number: 9031453)

Owner / Operator Contact Address

PREMIER PARK, 33 ROAD ONE,, WINSFORD INDUSTRIAL ESTATE,, WINSFORD, GB-CHE CW7 3RT, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143582

PMA Number

N/A

All Registered Proprietary Names

Polyethylene terephthalate polyester non-absorbable suture (SUPOLENE) ActivHeal® Actibride PGA RESORBA, PGA RESOQUICK, GLYCOLON CAPROLON MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2014-12-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-12-17
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-03-08
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2019-03-27
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-03-08
MXW	Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)	General, Plastic Surgery	Class 2	878.5010	2016-03-08
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-03-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-03-08
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-03-08
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-03-08

Official Correspondent

ROSE GUANG

US Agent Details

stephan Toupin Business: DAWA Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

ADVANCED MEDICAL SOLUTIONS GROUP PLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005433617	Medizin Produkte Neustadt GmbH (MPN)	Saal/Donau Bavaria, DE
3002673655	BIOMATLANTE	VIGNEUX DE BRETAGNE Loire-Atlantique, FR
8044178	Advanced Medical Solutions Ltd	WINSFORD Cheshire East, GB
3015330532	Medizin Produkte Neustadt GmbH (MPN)	Neustadt in Holstein Schleswig-Holstein, DE
9617175	Advanced Medical Solutions Limited	PLYMOUTH Devon, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

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

Registration Number	Establishment Name	Location
3005381997	LifeNet Health	Virginia Bch, VA, US
3010146686	Community Blood Center dba Solvita	Kettering, OH, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3003604053	SMITH & NEPHEW INC.	ANDOVER, MA, US
3014262693	Arthrex (Shanghai) Co., Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611459. Last updated year: 2026. Please use registration number 9611459 when referencing this establishment in official correspondence.