AUSA Medical Device Pvt Ltd

FDA Device Registration & Listing · Bangalore Karnataka, IN · Registration 3015924373

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
3015924373
FEI Number
3015924373
Entity Name
AUSA Medical Device Pvt Ltd
City/State/Country
Bangalore Karnataka, IN
Establishment Address
Plot no. 15B Bommasandara Industrial Area, Anekal Taluk, Bangalore Karnataka 560099, IN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Adroit USA Inc (Owner Number: 10037845)
Owner / Operator Contact Address
1043 Serpentine Lane, Suite A, Pleasanton, CA 94566, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Diablo Strain Relief OneMark NEEDLE, TROCAR W/ECHOBLAST - 21G 51679622-02 Percutaneous Access Needle with Echogenic Tip 51679622-01 NEEDLE, TROCAR W/ECHOBLAST - 18G Jedi 8FR Strain Relief FNA Expect EUS Aspiration Needle FNB Encor Probe DBS Counterweight Vercise System Tension Guide Sub Assembly 16TW SIgmoid Cannula Subassy Fixate Merlot Strain Relief Clottriever Components Slotted Needle, 17G FNB Expect EUS Slimline Needle FNA Accustick Vertiflex Instrument Platform (VIP) Kit Encor Probe FNB Acquire EUS FNB Needle FNA HH88EX

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-03-02
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2025-05-08
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2023-11-08
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-03-02
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-03-02
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-09-24
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-09-24
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2011-08-24
PJS Stimulator, Electrical, Implanted, For Essential Tremor Unknown Class 3 N/A 2019-06-20
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2019-06-20
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2019-06-20
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2024-06-13
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2026-03-10
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2026-03-10
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2026-03-02
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-06-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2022-06-21
SEF Central Venous Catheter With Manual Insertion System General Hospital Class 2 880.5200 2026-04-10
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-09-24
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-09-24
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2023-05-08
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2023-03-31
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2020-02-04
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-09-24
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-09-24
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2022-02-09

Official Correspondent

Arpan Bajaj

US Agent Details

Arpan Bajaj Business: Adroit USA Inc Email: arpan@adroitusa.net Phone: (510) 2991796

Related Public Records

Same Entity

Adroit USA 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
3005160949 ARMOR PLAST LTD Bangalore Karnataka, IN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241362 Surmodics,Inc. Pounce XL Thrombectomy System (PTS-1011-7F135) 2024-09-11
K220887 Inari Medical Mini-ClotTriever Thrombectomy System 2022-08-04
K250421 Inari Medical, Inc. InThrill™ Thrombectomy System 2025-05-12
K192036 Inari Medical ClotTriever Thrombectomy System 2019-08-29
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2012 Olympus America Inc. 2
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0027-2024 Bard Peripheral Vascular Inc 2
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013 Remington Medical Inc. 2
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014 Atossa Genetics, Inc. 2
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018 Bard Peripheral Vascular Inc 2
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015924373. Last updated year: 2026. Please use registration number 3015924373 when referencing this establishment in official correspondence.
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