Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1835959

FEI Number

3002340648

Entity Name

COOK BIOTECH, INC.

City/State/Country

West Lafayette, IN, US

Establishment Address

1425 INNOVATION PLACE, West Lafayette, IN 47906, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COOK BIOTECH, INC. (Owner Number: 9031415)

Owner / Operator Contact Address

1425 INNOVATION PLACE, --, West Lafayette, IN 47906, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cormatrix ECM for Pericardial Closure ECM for Pericardial Closure ProxiCor for Pericardial Closure Biodesign Anal Fistula Plug DynaMatrix Plus Extracellular Membrane DynaMatrix Biodesign Peyronie's Repair Graft Biodesign Tissue Graft Biodesign Dural Graft Biodesign 4-Layer Tissue Graft Biodesign 1-Layer Tissue Graft durasis DURAL GRAFT Biodesign Nipple Reconstruction Cylinder Biodesign Rectopexy Graft NRC Shield Biodesign Hernia Graft Biodesign Plastic Surgery Matrix Cormatrix ECM for Cardiac Tissue Repair ProxiCor for Cardiac Tissue Repair ECM for Cardiac Tissue Repair Fortify Flowable Extracellular Matrix Flowable Wound Matrix Biodesign Otologic Repair Graft Axoguard Nerve Protector NRC Template AxoGuard Nerve Connector Nipple Reconstruction Shield Extended Nipple Reconstruction Shield HaloShield Nipple Protector Extended HaloShield Nipple Protector Biodesign Enterocutaneous Fistula Plug Powder Extracellular Matrix Oasis Micro Micronized Wound Matrix Biodesign Duraplasty Graft Biodesign Otologic Butterfly Graft AxoGuard Nerve Connector Biodesign Hiatal Hernia Graft Durasis Dural Substitute Surgisis Biodesign Dural Graft Biodesign Surgisis Dural Graft Biodesign Dural Graft Cormatrix ECM for Vascular Repair VasCure for Vascular Repair ECM for Vascular Repair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2014-08-27
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2007-12-11
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2008-11-06
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2016-06-01
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2016-06-01
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2011-10-07
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2007-12-06
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-12-06
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2007-12-06
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2015-10-30
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2014-08-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2014-08-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2007-12-11
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2017-10-06
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2014-08-27
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-10-28
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2016-05-16
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2014-01-20
HWT	Template	Orthopedic	Class 1	888.4800	2015-10-30
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2017-03-01
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-10-20
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2009-10-08
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-10-09
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2013-10-23
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2024-05-29
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2007-12-11
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	General, Plastic Surgery	Class 2	878.3300	2014-07-08
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2014-07-08
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2007-12-11
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2014-08-27

Official Correspondent

Monica Bravo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOK BIOTECH, INC.

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
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835959. Last updated year: 2026. Please use registration number 1835959 when referencing this establishment in official correspondence.