INSTRUMENTARIUM SURGICAL CORP., INC.

FDA Device Registration & Listing · TERREBONNE Quebec, CA · Registration 9615857

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
9615857
FEI Number
3002409980
Entity Name
INSTRUMENTARIUM SURGICAL CORP., INC.
City/State/Country
TERREBONNE Quebec, CA
Establishment Address
1273 Rue Saint-Louis, TERREBONNE Quebec J6W 1K6, CA
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
INSTRUMENTARIUM SURGICAL CORP., INC. (Owner Number: 9041885)
Owner / Operator Contact Address
1273 RUE SAINT-LOUIS, --, TERREBONNE, CA-QC J6W 1K6, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INSTRUMENTARIUM INSTRUMENTARIUM instrumentarium INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM SURGICAL CORP. INC. INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM instrumentarium INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM SURGICAL CORP. INC. INSTRUMENTARIUM INSTRUMENTARIUM Instrumentarium INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM HEBU INSTRUMENTARIUM INSTRUMENTARIUM INSTRUMENTARIUM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2000-06-19
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2021-10-27
JZD Snare, Ear Ear, Nose, Throat Class 1 874.4420 2000-06-19
HWX Tap, Bone Orthopedic Class 1 888.4540 2015-08-20
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2000-06-19
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 2000-06-19
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2022-09-21
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2000-06-19
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-06-19
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2000-06-19
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2000-06-19
KAG Holder, Speculum, Ent General, Plastic Surgery Class 1 878.1800 2000-06-19
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2000-06-19
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2015-07-22
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2016-10-13
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-06-19
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
FWL Camera, Cine, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2015-09-03
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2015-07-27
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2016-09-06
HOA Compressor, Orbital Ophthalmic Class 1 886.4350 2000-06-19
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2015-07-22
KAY Punch, Nasal Ear, Nose, Throat Class 1 874.4420 2016-09-06
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2000-06-19
KBF Trephine, Sinus Ear, Nose, Throat Class 1 874.4420 2000-06-19
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2000-06-19
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2000-06-19
HXL Mallet General, Plastic Surgery Class 1 878.4800 2022-03-16
HOF Burr, Corneal, Manual Ophthalmic Class 1 886.4350 2000-06-19
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-07-22
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-06-19
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 2000-06-19
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2015-07-21
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2000-06-19
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 2015-07-22
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2000-06-19
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-07-05
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2019-12-13
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2000-06-19
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2000-06-19
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2015-07-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-22
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2000-06-19
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2000-06-19
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2015-08-04

Official Correspondent

JEAN-PAUL DAVID

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

INSTRUMENTARIUM SURGICAL CORP., 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
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009 Becton Dickinson and Company 1
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615857. Last updated year: 2026. Please use registration number 9615857 when referencing this establishment in official correspondence.
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