INKA SURGICAL INSTRUMENTS

FDA Device Registration & Listing · Jandakot Western Australia, AU · Registration 3023657851

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
3023657851
FEI Number
3023657851
Entity Name
INKA SURGICAL INSTRUMENTS
City/State/Country
Jandakot Western Australia, AU
Establishment Address
116 Cutler Road, Jandakot Western Australia 6164, AU
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
INKA Surgical Instruments (Owner Number: 10086662)
Owner / Operator Contact Address
116 Cutler Road, Jandakot, AU-WA 6164, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2025-09-26
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 2025-09-26
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-09-25
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2022-12-14
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2022-12-14
EKB Explorer, Operative Dental Class 1 872.4565 2022-12-01
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2022-12-05
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2022-12-19
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2025-09-26
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2025-09-25
HDE Hook, Fibroid, Gynecological Obstetrics/Gynecology Class 1 884.4520 2025-09-26
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2025-09-26
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2022-12-14
HTD Forceps General, Plastic Surgery Class 1 878.4800 2022-12-14
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2022-12-05
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2025-09-26
HTE Elevator General, Plastic Surgery Class 1 878.4800 2022-12-15
JZY Knife, Laryngeal Ear, Nose, Throat Class 1 874.4420 2025-09-26
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2022-12-15
HNK Probe, Trabeculotomy Ophthalmic Class 1 886.4350 2023-01-23
HSO Saw General, Plastic Surgery Class 1 878.4800 2022-12-14
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2023-01-23
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2023-01-25
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-12-05
EAX Mirror, Mouth Dental Class 1 872.4565 2022-12-01
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2022-12-01
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2022-12-16
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2023-01-23
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-12-01
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2022-12-16
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2025-09-26
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2022-12-01
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2022-12-16
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2025-09-25
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2022-12-14
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2025-09-26
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2022-12-14
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2023-01-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-12-19
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 2022-12-16
FXF Speculum, Illuminated General, Plastic Surgery Class 1 878.1800 2025-09-25
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2022-12-01
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2022-12-01
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2025-09-26
ELS Splint, Endodontic Stabilizing Dental Class 2 872.3890 2025-09-25
GCZ Retainer, Surgical General, Plastic Surgery Class 1 878.4800 2025-09-25
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2022-12-01
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2025-09-25
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2025-09-26
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-12-01
FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology Gastroenterology, Urology Class 2 876.5365 2025-09-25
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2022-12-16
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2022-12-16
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2025-09-25
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2022-12-16
FNS Ring Cutter General Hospital Class 1 880.6200 2025-09-25
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2023-05-16
HWK Trephine Orthopedic Class 1 888.4540 2022-12-15
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2025-09-26
KBT Punch, Tonsil Ear, Nose, Throat Class 1 874.4420 2025-09-26
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2022-12-19
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2022-12-05
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2022-12-16
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2025-09-26
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2022-12-15
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2022-12-01
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2022-12-15
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2022-12-05
HWJ Awl Orthopedic Class 1 888.4540 2022-12-15
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2022-12-01
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-12-01
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2022-12-01
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2025-09-26
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2025-09-25
HBD Handpiece (Brace), Drill Neurology Class 1 882.4325 2025-09-26
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2025-09-26
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2022-12-16
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2022-11-30
HXS Twister, Wire Orthopedic Class 1 888.4540 2023-01-23
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2022-12-15
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2025-09-26
HXW Bender Orthopedic Class 1 888.4540 2023-01-23
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2022-12-16
HTF Curette General, Plastic Surgery Class 1 878.4800 2022-12-15
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2022-12-19
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-12-01
KBG Trocar, Sinus Ear, Nose, Throat Class 1 874.4420 2022-12-16
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-01-25
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2022-12-05
HTX Rongeur Orthopedic Class 1 888.4540 2022-12-15
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2022-12-05
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2025-09-26
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2025-09-25
HWA Impactor Orthopedic Class 1 888.4540 2022-12-15
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2022-12-01
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-12-01
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2025-09-26
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2022-12-16
KTZ Caliper Orthopedic Class 1 888.4150 2025-09-26
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2022-12-16
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-09-25
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2025-09-26
HXR Spatula, Orthopedic General, Plastic Surgery Class 1 878.4800 2022-12-16
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2022-12-05
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2022-12-14
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2025-09-26
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2022-12-01
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2023-01-23

Official Correspondent

Carmen Kaiser

US Agent Details

German American Chamber of Commerce Inc German American Cham Business: German American Chamber of Commerce Inc Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

INKA Surgical Instruments
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
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K000397 Boston Scientific Corp SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL 2000-03-07
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K914226 E.I. Dupont DE Nemours & Co., Inc. ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK 1991-11-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0040-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number Establishment Name Location
8010890 PETER LAZIC GMBH TUTTLINGEN Baden-Wurttemberg, DE
3006098219 ADEPT MEDICAL LTD AUCKLAND, NZ
3006142527 BLACK & BLACK SURGICAL, INC. Tucker, GA, US
3008770252 NOVO SURGICAL, INC. Westmont, IL, US
3002808270 USTOMED INSTRUMENTE GMBH & CO. KG Tuttlingen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023657851. Last updated year: 2026. Please use registration number 3023657851 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.