STERI-TEK

FDA Device Registration & Listing · Fremont, CA, US · Registration 3012448339

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
3012448339
FEI Number
3012448339
Entity Name
STERI-TEK
City/State/Country
Fremont, CA, US
Establishment Address
48225 Lakeview Blvd, Fremont, CA 94538, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Steri-Tek (Owner Number: 10051493)
Owner / Operator Contact Address
48225 Lakeview Blvd., Fremont, CA 94538, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Biodesign Staple Line Reinforcement Finesse™ Injectable PTA Balloon Dilatation Catheter Donaldson Decompression Needle (DDN) Band Aid Brand microMend PRO microMend BackVive Restrata Latera Absorbable Nasal Implant and Delivery Device Speed Torque EntreVu Cannula AlloFuse Gel, AlloFuse Putty SSPC Delivery Catheter Flowable Wound Matrix Flexagon SFM Plus OTOLoc System (FlesFie Universal Laparoscopic Delivery) AccuLif TL8-12 Implant Tasso-M20 Blowfish® Transbronchial Micro-Infusion Device (Bronchoscope, flexible or rigid) CPS Locator 3D Delivery Catheter Sentinel CPS Helix Locking Tool Revolution Suture Passer Bullfrog® Micro-Infusion Device (Catheter, continuous flush) Biodesign Staple Line Reinforcement IMPEDE Embolization Plug, 10mm IMPEDE Embolization Plug, 5mm IMPEDE Embolization Plug, 7mm SSPC NXT Delivery Catheter AlloFuse Plus Paste, AlloFuse Plus Putty NanoFUSE Bioactive Matrix; Bio V BP Bioactive Glass with DBM Putty LUKE BX Biopsy Forceps NanoFUSE Bioactive Strip Tasso-M20; Tasso+ miLOOP Dexcom G6 CGM System Propel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2020-08-06
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2023-01-24
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-02-27
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2024-01-10
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2020-10-07
QSZ Absorbable Synthetic Wound Dressing Unknown Class U N/A 2018-11-12
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2016-08-11
MLY Vapocoolant Device Unknown Class U N/A 2021-04-05
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2020-10-05
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2016-08-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-04-27
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2020-04-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-09-25
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-01-11
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2023-01-24
SAH Magnetic Compression Anastomosis System General, Plastic Surgery Class 2 878.4816 2026-06-19
ENW Catheter, Nasopharyngeal Ear, Nose, Throat Class 1 874.4175 2016-03-25
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2021-07-13
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2018-02-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-05-22
PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures Cardiovascular Class 2 870.1251 2020-04-04
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2024-04-22
HWQ Passer Orthopedic Class 1 888.4540 2017-10-23
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2018-02-23
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2021-09-17
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2021-09-17
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2018-07-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-12-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-04-27
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2020-04-27
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2020-01-14
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-01-14
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2024-07-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-01-14
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2018-03-22
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2021-07-13
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2018-02-23
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2022-03-25
OWO Drug-Eluting Sinus Stent Unknown Class 3 N/A 2022-07-18

Official Correspondent

Larry Nichols Nichols

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Steri-Tek
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
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28

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.
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012448339. Last updated year: 2026. Please use registration number 3012448339 when referencing this establishment in official correspondence.
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