FDA 510(k) Premarket Notification K220540: ProGrip Self-Gripping Polypropylene Mesh

Submission Details & Decision

Normalized public record details for 510(k) notification K220540.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K220540

Applicant / Sponsor

Covidien

Device Name

ProGrip Self-Gripping Polypropylene Mesh

Product Code

FTL

Decision Date

2022-09-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Special

Third Party Flag

Date Received

2022-02-25

Related Establishments / Registrations

COOK INCORPORATED Registration: 1000393132 View Registration
Linvatec Corporation Registration: 1017294 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
TECHNICAL PRODUCTS, INC. Registration: 1061771 View Registration
DEMETECH CORP. Registration: 1064584 View Registration
ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
DAVOL INC., SUB. C.R. BARD, INC. Registration: 1213643 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
J-PAC, LLC. Registration: 1221051 View Registration
DePuy Mitek, Inc. Registration: 1221934 View Registration
Primo Medical Group, INC Registration: 1222928 View Registration
R.K. Manufacturing Registration: 1226146 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
ETHICON, INC. Registration: 1614993 View Registration
TORNIER, INC. Registration: 1649390 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
COOK BIOTECH, INC. Registration: 1835959 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Sterigenics U.S., LLC Registration: 2022435 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
IMPLANTECH ASSOCIATES, INC. Registration: 2028924 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
LIFE SCIENCE OUTSOURCING, INC. Registration: 2031093 View Registration
NUVASIVE, INC. Registration: 2031966 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
PRESERVATION SOLUTIONS, INC. Registration: 2132588 View Registration
MEDTRONIC, INC. Registration: 2182208 View Registration
ETHICON, INC. Registration: 2210968 View Registration
Sterigenics U.S., LLC Registration: 2219920 View Registration
GENADYNE BIOTECHNOLOGIES, INC. Registration: 2435947 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
DSM Biomedical, Inc. Registration: 2530154 View Registration
ETHICON, LLC. Registration: 2648650 View Registration
Johnson & Johnson MEDICAL GmbH Registration: 3002294946 View Registration
STERIS SPA Registration: 3002806603 View Registration
IONISOS Registration: 3002807295 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration
SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration
MEDELA AG Registration: 3002807523 View Registration
MEDTRONIC B.V. (EOC) Registration: 3002807561 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
Integra LifeSciences Corporation Registration: 3003418325 View Registration
W. L. GORE & ASSOCIATES, INC. Registration: 3003910212 View Registration
PFM MEDICAL TITANIUM GMBH Registration: 3003936139 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
MAST BIOSURGERY USA INC. Registration: 3004661493 View Registration
HEALTHIUM MEDTECH LIMITED Registration: 3004944585 View Registration
Boston Scientific Corporation Registration: 3005619880 View Registration
BARD SHANNON LIMITED Registration: 3005636544 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
KOLLSUT INTERNATIONAL INC Registration: 3005953126 View Registration
ALLWIN MEDICAL DEVICES, INC. Registration: 3005987240 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
POLY-MED, INC. Registration: 3006121828 View Registration
STERLAB Registration: 3006174295 View Registration
Surgical Specialties Corporation Limited (UK) Registration: 3007109793 View Registration
Sterigenics SAS Registration: 3007156625 View Registration
Aroa Biosurgery Ltd Registration: 3007321028 View Registration
Systagenix Wound Management Manufacturing Limited Registration: 3007663067 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
Eurofins STERIPAC GMBH Registration: 3009217531 View Registration
Synergy Health Ede BV Registration: 3009337401 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
SYNTHES GMBH Registration: 3009417901 View Registration
Primo Medical Group, Inc Registration: 3009420598 View Registration
NOVUS SCIENTIFIC INC Registration: 3009514842 View Registration
BIOCER ENTWICKLUNGS-GMBH Registration: 3009749957 View Registration
Synergy Health Ede BV Registration: 3009756327 View Registration
SSP-SiMatrix Inc. Registration: 3009976880 View Registration
Smith & Nephew, Inc. Registration: 3010034780 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
IONISOS Registration: 3010178296 View Registration
NOVUS SCIENTIFIC AB Registration: 3010187263 View Registration
LOCKDOWN SURGICAL. INC. Registration: 3010237768 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
STERISERVICES Registration: 3010383847 View Registration
TELA BIO, INC. Registration: 3010513348 View Registration
INTERNATIONAL LIFE SCIENCES Registration: 3010673515 View Registration
Genadyne Biotechnologies, Inc. Registration: 3011582224 View Registration
DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
EUROFINS INPAC MEDIZINTECHNIK GMBH Registration: 3013111980 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
GMED Healthcare BVBA ( a Johnson & Johnson Company) Registration: 3014272734 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Registration: 3014479313 View Registration
SURGICAL INNOVATION ASSOCIATES, INC. Registration: 3015194982 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Medtronic, Inc. Registration: 3015544746 View Registration
CHAMBERLAIN TECHNOLOGIES, LLC Registration: 3015860534 View Registration
ENDOMED, LLC Registration: 3016248634 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
ETHICON, INC. Registration: 3017102971 View Registration
BRDH Registration: 3017196117 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
DEEP BLUE MEDICAL ADVANCES, INC. Registration: 3017492634 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
ConMed Corporation Registration: 3019101334 View Registration
HEALTHIUM MEDTECH LIMITED Registration: 3020983460 View Registration
MEDINEEDLE - RESCUE GROUP RETTUNGSDIENST Registration: 3021194552 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
Polyganics Holding BV Registration: 3022140316 View Registration
MDTGLOBAL, A.S. Registration: 3024021261 View Registration
PFM MEDICAL MSG GMBH Registration: 3026560514 View Registration
SHANGHAI SUOKANG MEDICAL IMPLANTS CO., LTD. Registration: 3027616027 View Registration
CELESTRAY BIOTECH COMPANY, LLC. Registration: 3027699572 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
GRANT TECHNOLOGIES LLC Registration: 3031978586 View Registration
SPECIALTY SURGICAL PRODUCTS, INC. Registration: 3031984 View Registration
THERAMICRO Registration: 3032412536 View Registration
Artelon Registration: 3033273526 View Registration
BOYLSTON SURGICAL LLC Registration: 3033302333 View Registration
Genadyne Biotechnologies, Inc. Registration: 3039256597 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
LOCKDOWN MEDICAL LIMITED Registration: 8020712 View Registration
Smith & Nephew Medical Ltd Registration: 8043484 View Registration
ENTACO LTD. Registration: 8043734 View Registration
XIROS LTD Registration: 8044102 View Registration
HERNIAMESH SRL Registration: 9614846 View Registration
SOFRADIM PRODUCTION Registration: 9615742 View Registration
Cousin Biotech Registration: 9616062 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
PFM Medical GmbH Registration: 9617465 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.