Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2126670

FEI Number

2126670

Entity Name

SCANLAN INTERNATIONAL, INC.

City/State/Country

Saint Paul, MN, US

Establishment Address

1 SCANLAN PLZ, Saint Paul, MN 55107, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

SCANLAN INTERNATIONAL, INC. (Owner Number: 2126670)

Owner / Operator Contact Address

ONE SCANLAN PLAZA, --, Saint Paul, MN 55107, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCANLAN Suction Sytem Instruments SUNDT graduated suction system SCANLAN® THORACOSCOPIC WOLF SUCTION SCANLAN® THORACOSCOPIC DAMICO SUCTION SCANLAN® THORACOSCOPIC DENNIS SUCTION SCANLAN® THORACOSCOPIC DAMICO SUCTION INSTRUMENT SCANLAN® SUNDT Graduated Suction System Brush Set POTTS-SMITH SUCTION FORCEPS SCANLAN® DEBAKEY SUCTION FORCEPS SCANLAN® BROLI-ADSON SUCTION FORCEPS SCANLAN® Van Gompel Suction System KNOT TIER SCANLAN SUTURE PUSHER Scanlan Thoracoscopic Scissors SCANLAN® Khan Decortication Grasper SCANLAN® Thoracoscopic Dennis Clamp SCANLAN® Endoscopic Micro Scissors SCANLAN® Thoracoscopic Resano Forceps SCANLAN® Thoracoscopic Suture Cutter SCANLAN® Thoracoscopic DeBakey Cross Clamp SCANLAN® Minimally Invasive Micro Scissors SCANLAN® Reliance Clamp Applier SCANLAN® Thoracoscopic Fine Needle Holder SCANLAN® Thoracoscopic Node Grasper SCANLAN® Thoracoscopic Chitwood Jacobson Valve Forceps SCANLAN® Thoracoscopic Chitwood DeBakey Clamp SCANLAN® Thoracoscopic Needle Holder SCANLAN® Endoscopic Chitwood Knot Tier/Pusher SCANLAN® Thoracoscopic Gonzalez-Rivas Dissector SCANLAN® Thoracoscopic Reliance Bulldog Clamp Applier SCANLAN® Thoracoscopic DeBakey Dissector SCANLAN® Thoracoscopic Jacobson Needle Holder SCANLAN® Thoracoscopic Chitwood Suture Cutter SCANLAN® Thoracoscopic DeBakey Forceps SCANLAN® Endoscopic Fine Needle Holder SCANLAN® Thoracoscopic D AMICO Mediatinoscopy Biopsy Forcep SCANLAN® Thoracoscopic Dennis Dissector SCANLAN® Thoracoscopic Adson Forceps SCANLAN® Thoracoscopic SuperCut Micro Scissors SCANLAN® Thoracoscopic Jacobson Forceps SCANLAN® Endoscopic Jacobson Needle Holder SCANLAN® Thoracoscopic Clamp SCANLAN® D AMICO Mediatinoscopy Biopsy Forcep SCANLAN® Thoracoscopic Grasper SCANLAN® Thoracoscopic Chitwood DeBakey Needle Pulling Tissue Forceps SCANLAN® Thoracoscopic Jacobson Debakey Forceps SCANLAN® Thoracoscopic DeBakey Clamp SCANLAN® Thoracoscopic Foerster Clamp SCANLAN® Thoracoscopic DeBakey Needle Pulling Tissue Forceps SCANLAN® Thoracoscopic Duval Clamp SCANLAN® Thoracoscopic SuperCut Chitwood Dissecting Scissors SCANLAN® Thoracoscopic Platform Forceps SCANLAN® Thoracoscopic Allis Forceps SCANLAN® Thoracoscopic Harken #1 Clamp SCANLAN® Thoracoscopic Gonzalez-Rivas Foerster Clamp SCANLAN® Rocco Nodule Clamp SCANLAN® Thoracoscopic DeMartel Scissors SCANLAN® Thoracoscopic Russian Forceps SCANLAN® Thoracoscopic Axial Needle Holder SCANLAN® Gonzalez-Rivas Dissector SCANLAN® Thoracoscopic Jacobson DeBakey Forceps SCANLAN® Thoracoscopic Harken #2 Clamp SCANLAN® Thoracoscopic SuperCut Metzenbaum Scissors SCANLAN® Thoracoscopic Debakey Cooley Forceps SCANLAN® Thoracoscopic Cassivi Clamp Scanlan® Scanturian MIS DeBakey Forceps Scanlan® Scanturian MIS Resano Forceps SCANLAN® Scanturian MIS POTTS SUPER CUT SCISSORS Scanlan® Scanturian MIS Needle Holder SCANLAN® Scanturian MIS SUPER CUT SCISSORS Scanlan Thoracoscoptic Clamp Scanlan Thoracoscoptic Needle Holde Scanlan Thoracoscoptic Forceps Scanlan Thoracoscopic Instruments SCANLAN SURG I PAWS SCANLAN SUTURE-STATT SCANLAN VASCU-STATT SCANLAN® Valvulotome SCANLAN® In Situ Valvulotome SCANLAN TIP GUARD SCANLAN SURG-I-BAND SCANLAN EASY TAG SCANLAN TRAVELER SCANLAN® Orthopedic Surgical Scissors SCANLAN® SUPER-CUT scissors SCANLAN® ULTRA SHARP scissors PrepMARK surgical skin marker SCANLAN MULTI-COLORED scanlan biopsy needle SCANLAN® Ronguer SCANLAN® Dennis Rib Cutter DENLAN MAGNIFYING LOUPE SCANLAN ENDARSECTOR SCANLAN LIGATURE GUIDE SCANLAN® Curette SCANLAN® Speculum SCANLAN MEMORY Mirror Instrument SCANLAN® Elevator Miller Periosteal Elevator RADIOMARK GRAFTMARKER A/C LOCATOR SCANLAN® Cannula SCANLAN® OSTEOTOME SCANLAN CRAFOORD CONTRACTOR DEBAKEY MULTIPLE (MAYO ETC.) METZENBAUM SCANLAN® Dennis Multi-Purpose Clamps SCANLAN® Satinsky Occlusion Clamps SCANLAN® Hunter-Satinsky Aortic Clamps SCANLAN® Anastomosis Clamps SCANLAN® Vascular Clamps SCANLAN® Vascular Clamp SCANLAN® Dennis Anastomosis Clamps SCANLAN® Tangential Occlusion Clamps SCANLAN® Dennis Aortic Anastomosis Clamps SCANLAN® Dennis Clamps SCANLAN® Pollock Aortic Clamps SCANLAN® Baby Vascular Clamps SCANLAN® Lambert-Kay Anastomosis Clamps SCANLAN® Peripheral Vascular Clamps SCANLAN® Aortic Aneurysm Clamps SCANLAN® Heifetz Temporary Occlusion Clip SCANLAN RIB SHEARS SCANLAN PLASTER SHEARS SCANLAN LISTON DOUBL SCANLAN REUSABLE BIOPSY NEEDLE SCANLAN ASPIRATION NEEDLE SCANLAN BRYANT MITRAL HOOK SCANLAN BEALL SCISSORS SCANLAN® Vascular Tunneler SCANLAN® Vascular Tunneling System SCANLAN® A/V Access Tunneling Grasping Forceps SCANLAN® Vascular Tunneling Sheath and Bullet Tip SCANLAN VENOUS VALVE SCISSORS SCANLAN STERILIZATION TRAY SCANLAN AORTIC VEIN PUNCH SCANLAN® Super Cut¿ Microsurgical Knife SCANLAN® Rasp SCANLAN® Adson Forceps SCANLAN® Bengolea Forceps SCANLAN® Bailey Forceps SCANLAN® Phlebectomy Haemostat SCANLAN® Vascular Forceps SCANLAN® Delicate Mosquito Forceps SCANLAN® DeBakey Cooley Forceps SCANLAN® Ochsner Forceps SCANLAN® Hemostat SCANLAN® Crafoord Artery Forceps SCANLAN® Hartman Mosquito Forceps SCANLAN® SURG-I-LOOP® PLUS SURG-I-LOOP® SILICONE LOOPS SCANLAN® Vascular Tunneler SCANLAN® VASCU-STATT APPLIERS SCANLAN® VASCU-STATT APPLIER SCANLAN® Tunneler SCANLAN® HEIFETZ TEMPORARY CLIP SCANLAN Caliper SCANLAN® YASARGIL-TYPE APPLING FORCEPS SCANLAN® Stern Chest Tube Passer SCANLAN® A/V Access Tunneler SCANLAN® HEIFETZ CLIP APPLIER SCANLAN® A/V Access Tunneler Full Curve SCANLAN® A/V Access Tunneler Partial Curve SCANLAN® YASARGIL-TYPE TEMPORARY CLIP SCANLAN® CALIPER SCANLAN® Stern Chest Tube Passer SCANLAN® Forceps SCANLAN® CardioVasive Retractor System SCANLAN® CardioVasive/Thoracoscopic Port Oval Retractor Morse Favaloro Style Retractor Sternal Approximator SCANLAN PEDIATRIC RETRACTOR Finochietto Neonatal Sternal Retractor SCANLAN® Rib Spreader Chaux Valve Retractor Scanlan® Loftus Two Level ACDF Distractor Bailey Pediatric Retractor Pediatric Titanium Cardiovascular Retractor Bailey Finochietto Titanium Pediatric Retractor Pediatric Titanium Retractor Pediatric Spring Wire Retractor Adson Retractor Lung Retractor lonescu Double Ended Leaflet Valve Retractor SCANLAN WILKINSON A Cooley Sternal Retractor Cochran Pediatric Retractor SCANLAN® CardioVasive Retractor Self-retaining Spring Wire Retractor Finochietto Sternal Retractor M.D. Titanium Retractor Bryant Mitral Hook SCANLAN® I.M.A./Sternal Retractor A/V Fistula Retractor SCAN-VU Retractor IMA Dissection Rake/Blade System SCANLAN® Telescopic Articulated Immobilizer (S.T.A.I.) Shannahan Special Sternal Spreader Finochietto Retractor Sanders Lung Retractor Scanturian Scanlan Ligator Special Garrett Vascular Dilator Special Vasculator Dilator Garrett Vascular Dilator Vascular Graduated Dilator SCANLAN® MEMORY Vascular Graduated Dilator SCANLAN® MEMORY Garrett Vascular Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2007-11-16
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2001-08-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-05
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-03-09
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2014-06-09
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2001-08-17
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1977-12-19
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2007-03-28
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-11-15
HTX	Rongeur	Orthopedic	Class 1	888.4540	1977-12-19
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	1977-12-19
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1984-08-24
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1977-12-19
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1977-12-19
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2009-07-24
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-11-19
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	1977-12-19
MAB	Marker, Cardiopulmonary Bypass (Vein Marker)	Cardiovascular	Class 2	870.3450	2008-11-19
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-10
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	1977-12-19
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	1978-03-09
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1977-12-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-11-05
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1978-03-09
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1991-05-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1977-12-19
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-12-31
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1977-12-19
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	1977-12-19
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-12-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-11-19
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1977-12-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1977-12-19
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2007-11-05
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2007-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SCANLAN INTERNATIONAL, 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2126670. Last updated year: 2026. Please use registration number 2126670 when referencing this establishment in official correspondence.