Cook Incorporated

FDA Device Registration & Listing · Spencer, IN, US · Registration 1825146

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1825146
FEI Number
1825146
Entity Name
Cook Incorporated
City/State/Country
Spencer, IN, US
Establishment Address
1100 W Morgan St, Spencer, IN 47460, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
COOK, INC. (Owner Number: 1820334)
Owner / Operator Contact Address
750 DANIELS WAY, Bloomington, IN 47404, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

One-Step Suprapubic Introducer Cook Sterilization Case UPJ Occlusion Balloon Catheter Set Soules Intrauterine Insemination Catheter San Antonio Stopcock Brush Biopsy Set Odyssey Holmium Laser System Novy Corneal Cannulation Set Greene Renal Transplant Stent Set Wire Guide With Hydrophilic Coating Laser Ureteral Catheter Side Arm Adapter Foley Adapter/Connector Luer Lock Cap Disposable Stopcock Flexor Vision Endoscopic Introducer/Extractor Pediatric Flexor Ureteral Access Sheath Percutaneous Neonatal Pigtail Nephrostomy Set Pediatric Nephrostomy Stent Set Salle Intraoperative Pyeloplasty Stent Set With 6cm Stylet Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet Sof-Flex® Double Pigtail Ureteral Stent Set Sof-Flex® Multi-Length Ureteral Stent Set Surgical Urine Drain Pouch Set Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating Dual Lumen Ureteral Access Catheter Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating Flexi-Tip® Dual Lumen Ureteral Access Catheter MagniCore Precision Chiba iMRI Needle MagniCore Precision Coaxial iMRI Needle Amplatz Renal Dilator Set Koyle Diaper Stent Zaontz Urerthral Stent Firlit-Kluge Urethral Stent Silicone Rectal Balloon Cook 810 Set Desilets-Hoffman Introducer Set Desilets-Hoffman Introducer Set With Radiopaque Band Williams Cystoscopic Injection Needle Elongated Cup Biopsy Forceps Cup Biopsy Forcepts Selikowtiz Ureteroscopic Knife Williams Cystoscopic Injection Needle Hatter Flexible Cystoscopy Aspiration Tube Connecting Tube OBrien Suprapubic Peel-Away® Access Set Cook® SP Tube Introducer Set Rutner Universal Wedge Catheter Cone Tip Ureteral Catheter with Open-End Cone Tip Ureteral Catheter CHIBA DECOMPRESSION SET Universal Check Flo Adapter Female Luer Lock Cap Dual Male Luer Lock Adapter Dual Check Valve Anesthetic Gel Adapter Endoscopic Tuohy Borst Adapter Ultraxx Nephrostomy Balloon Set Ultraxx Nephrostomy Balloon Set with TFE Sheath FUSION LITHOTRIPSY EXTRACTION BASKET MEMORY SOFT WIRE BASKET MEMORY HARD WIRE BASKET THE WEB EXTRACTION BASKET Soft-Pass EchoTip Embryo Transfer Catheter Pivet Guide Embryo Transfer Catheter Set Soft-Pass EchoTip Embryo Transfer Catheter Set Soft-Pass Embryo Transfer Catheter Set Urethral Dilator Set Onik-Cohen Percutaneous Access Set Selective Salpingography Catheter Intrauterine Access Balloon Catheter Malecot Nephrostomy Catheter/Stent Set Frova Intubating Introducer with Rapi-Fit Adapters Frova Intubating Introducer with Stiffening Cannula Deflectable Brush Biopsy Set VersaTube Tapered Tracheostomy Tube with Disposable Inner Ca Bakri Essential Postpartum Balloon Disposable Cervical Dilators Cook Silicone Balloon HSG Catheter Cook Silicone Balloon HSG Catheter With Closed End And Sideport Black Silicone Filiform Double Pigtail Ureteral Stent Set Non-Toxic Syringe Vacuum Syringe Taylor Gel Adapter Guardia Access Nano Embryo Transfer Catheter Amplatz Renal Introducer Amplatz Radiopaque TFE Sheath Amplatz Renal Dilator Set Catheter for Use with Amplatz Renal Dilator Set Clear Amplatz Sheath with Radiopaque Stripe Amplatz Dilator Laparoscopic Myoma Screw Hysteroscopic Myoma Screw Modified Novy Cornual Cannulation Set Flexor Ureteral Access Sheath with AQ Hydrophilic Coating Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating Ball Tip Fulgurating Electrode Balloon Ureteral Dilator Set Balloon Ureteral Dilator Cook Chorionic Villus Sampling Set EchoTip® Disposable Two-Part Trocar Needle Skinny Needle® with Chiba Tip Percutaneous Entry Set Disposable Two-Part Trocar Needle Percutaneous Entry Set (EchoTip) EchoTip®Skinny Needle® with Chiba Tip Pursuit Balloon Dilation Catheter Ureteral Dilation Balloon Ascent AQ Ureteral Dilation Balloon Rhapsody® H-30® Holmium Laser System Cervical Mucus Aspiration Set Roadrunner Biliary Wire Guide ACROBAT CALIBRATED TIP WIRE GUIDE FUSION WIRE GUIDE LOCKING DEVICE DELTA WIRE GUIDE TRACER METRO DIRECT WIRE GUIDE ACROBAT 2 CALIBRATED TIP WIRE GUIDE ROADRUNNER WIRE GUIDE UroStream Hydrophilic Wire Guide STANDARD WIRE GUIDE Goldstein SonoBiopsy Catheter Flexipet, Adjustable Handle Set Replacement O-Ring Set Use With K-MPH-1000 Angled Tip Ureteral Catheter Set Angled Tip Ureteral Catheter Set With Bentson PTFE Wire Guide Angled Tip Ureteral Catheter with Bentson PTFE-Coated Wire Guide Pigtail Ureteral Catheter Set, Left Pigtail Ureteral Catheter With Sof-Flex® AQ® Pigtail Ureteral Catheter Set, Right Peel Away Introducer Stamey Percutaneous Loop TURP Suprapubic Catheter Set Percutaneous Malecot Nephrostomy Catheter Set Stamey Percutaneous Suprapubic Catheter Set Sof-flex Loop Suprapubic Catheter Set Margolin HSG Cannula Stonebreaker Pneumatic Lithotripter Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe Ultraxx Nephrostomy Balloon with TFE Sheath TAO Brush I.U.M.C. Endometrial Sampler MADDURI URETERAL STONE PUSHING CATHETER Ultrathane Endoureterotomy Stent Set Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether Universa Firm Ureteral Stent Set with Hydrophilic Coating Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether Check-Flo® Adapter with Side-Arm and Stopcock Tuohy-Borst Adapter Check-Flo® Adapter Endoscopic Cap Universal Check-Flo® Adapter Side-Arm Adapter - Male Luer Lock and Touhy-Borst Adapter Kwart Retro-Inject Ureteral Stent Set Soft-Pass Coaxial Insemination Catheter Shepard Intrauterine Insemination Catheter Insemi-Cath Pigtail Ureteral Catheter Set AQ Hydrophilic Dual Lumen Ureteral Access Catheter Cook Coagulator Probe Cook-Cope Loop Nephrostomy Catheter Ultrathane® Suprapubic Set With Mac-Loc® Ultrathane® Nephrostomy Set With Mac-Loc® Cook-Cope Loop Nephrostomy Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2020-05-05
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-02-23
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2020-09-16
HDR Cap, Cervical Obstetrics/Gynecology Class 2 884.5250 2012-02-22
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-10-08
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2012-02-22
FFH Collector, Urine, Pediatric, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2016-01-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-02-22
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2016-01-27
MOV Catheters, Salpingography Obstetrics/Gynecology Class 2 884.4530 2012-02-22
KGY Bag, Intestine General, Plastic Surgery Class 1 878.4100 2016-01-27
MFD Cannula, Intrauterine Insemination Obstetrics/Gynecology Class 2 884.5250 2015-06-03
GED Brush, Dermabrasion, Manual General, Plastic Surgery Class 1 878.4800 2016-01-27
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2020-03-27
LJE Catheter, Nephrostomy Unknown Class U N/A 2015-06-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-03-12
EYI Adaptor, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2012-02-23
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2012-02-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-02-22
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2012-02-22
FFS Image, Illumination, Fiberoptic, For Endoscope Gastroenterology, Urology Class 2 876.1500 2012-02-22
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2012-02-22
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2012-02-22
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-02-23
MPR Stent, Bladder, Fetal Unknown Class f N/A 2017-07-27
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2012-02-22
LJE Catheter, Nephrostomy Unknown Class U N/A 2020-09-08
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2015-06-08
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-06-04
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2015-06-03
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2020-04-15
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 2012-02-23
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2019-08-28
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2015-06-03
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2011-12-23
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2007-11-19
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2020-03-23
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2015-06-08
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2015-06-08
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-07-17
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2012-02-22
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2019-08-23
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2016-02-03
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2016-02-03
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2012-02-23
FBW Filiform And Filiform Follower Gastroenterology, Urology Class 1 876.5520 2016-01-26
HDR Cap, Cervical Obstetrics/Gynecology Class 2 884.5250 2015-06-03
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2009-10-07
HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) Obstetrics/Gynecology Class 2 884.1300 2012-02-22
KNA Instrument, Manual, Specialized Obstetric-Gynecologic Obstetrics/Gynecology Class 2 884.4530 2015-06-03
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2016-01-27
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2019-09-09
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2012-02-22
KNA Instrument, Manual, Specialized Obstetric-Gynecologic Obstetrics/Gynecology Class 2 884.4530 2015-06-09
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2012-02-23
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2016-01-27
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2007-11-20
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2020-03-23
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2020-03-19
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 1992-12-12
EYK Connector, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2012-02-23
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2015-06-03
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2015-06-03
LJE Catheter, Nephrostomy Unknown Class U N/A 2019-06-20
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2014-02-13
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 1992-12-12
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2020-05-19
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2012-05-10
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2012-05-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-06-27
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2014-12-11
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2016-01-27
LJE Catheter, Nephrostomy Unknown Class U N/A 2015-06-09
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2017-07-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2012-02-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2012-02-22
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-09-15
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2020-03-24
LJE Catheter, Nephrostomy Unknown Class U N/A 2020-03-24
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2019-05-28
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2020-10-12
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2020-10-12
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2011-03-31
OQY Intrauterine Tamponade Balloon Obstetrics/Gynecology Class 2 884.4530 2023-02-08
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2012-02-23
KNA Instrument, Manual, Specialized Obstetric-Gynecologic Obstetrics/Gynecology Class 2 884.4530 2015-06-10
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-09-15
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2016-01-27
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-09-04
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2016-08-25
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2012-02-23
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2019-09-09
LJE Catheter, Nephrostomy Unknown Class U N/A 2019-05-28
HHO Screw, Fibroid, Gynecological Obstetrics/Gynecology Class 2 884.4530 2012-02-22
NNX Device, Incontinence, Urosheath Type, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2016-01-27
MOV Catheters, Salpingography Obstetrics/Gynecology Class 2 884.4530 2020-06-18
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2019-08-29
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2012-02-22
FEX Instrument, Catheter, Punch Gastroenterology, Urology Class 1 876.5090 2008-02-26
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2016-01-27
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2004-04-12
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2019-07-31
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2010-10-18
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2016-01-27
LLX Catheter, Sampling, Chorionic Villus Unknown Class 3 N/A 2012-02-22
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2015-07-21
LJE Catheter, Nephrostomy Unknown Class U N/A 2020-06-18
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2003-07-07
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2016-01-27
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2012-02-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-07-08
HFC Aspirator, Endocervical Obstetrics/Gynecology Class 2 884.1050 2012-02-22
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2016-01-27
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-07-27
KNA Instrument, Manual, Specialized Obstetric-Gynecologic Obstetrics/Gynecology Class 2 884.4530 2015-06-03
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2015-03-05
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2016-01-27
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2015-06-10
PGK Cannula, Injector, Uterine, Endometrial Biopsy Obstetrics/Gynecology Class 2 884.4530 2012-02-22
HFF Aspirator, Endometrial Obstetrics/Gynecology Class 2 884.1060 2012-02-22
MQJ Micromanipulators And Microinjectors, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6150 2019-06-20
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2016-01-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2020-03-12
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2020-08-17
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-08-13
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2012-02-22
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-03-10
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2012-02-22
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2007-11-27
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2015-06-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-06-05
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2016-01-27
LJE Catheter, Nephrostomy Unknown Class U N/A 2019-04-02
HFE Brush, Endometrial Obstetrics/Gynecology Class 2 884.1100 2018-04-24
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device Gastroenterology, Urology Class 2 876.1620 2015-06-08
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-09-23
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-05-13
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2020-03-23
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-09-13
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2019-01-08
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2015-10-19
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2012-02-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-02-22
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2021-04-23
LJE Catheter, Nephrostomy Unknown Class U N/A 2021-04-23
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2015-06-10
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2015-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOK, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011050534 Cook Incorporated Canton, IL, US
3012766489 COOK, INC. Bloomington, IN, US
1000393132 COOK INCORPORATED ELLETTSVILLE, IN, US
1820334 Cook Incorporated Bloomington, IN, US

Related 510(k) Records

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The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1825146. Last updated year: 2026. Please use registration number 1825146 when referencing this establishment in official correspondence.
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