FDA Registration
Active
🇦🇺 Australia
INKA SURGICAL INSTRUMENTS
Reg #: 3023657851
·
FEI: 3023657851
·
Expires 2026
Products
139
Proprietary Names
1
Establishment Types
1
Classifications
139
Registration Details
- Registration Name
- INKA SURGICAL INSTRUMENTS
- Registration Number
- 3023657851
- FEI Number
- 3023657851
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 116 Cutler Road
- City
- Jandakot Western Australia
- Country
- AU
Owner / Operator
- Firm Name
- INKA Surgical Instruments
- Operator Number
- 10086662
- Address
- 116 Cutler Road
- City
- Jandakot
- State
- Western Australia
- Postal Code
- 6164
- Country
- AU
- Correspondent
- Carmen Kaiser
US Agent
- Business Name
- German American Chamber of Commerce Inc
- Contact Name
- German American Chamber of Commerce Inc German American Cham
- Address
- 80 Pine St Fl 24
- City
- New York
- State
- NY
- ZIP
- 10005
- Country
- US
- [email protected]
- Phone
- 212 9748830
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2025-09-25 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2022-12-14 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2022-12-14 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2022-12-01 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2022-12-05 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-12-19 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2025-09-26 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2025-09-25 |
| Hook, Fibroid, Gynecological | HDE | Class 1 | Obstetrics/Gynecology | No | 2025-09-26 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2022-12-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-12-14 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2022-12-05 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2022-12-15 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2022-12-15 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2023-01-23 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2022-12-14 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-01-23 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2023-01-25 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2022-12-05 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2022-12-01 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2022-12-01 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2023-01-23 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-12-16 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2022-12-01 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2025-09-25 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2022-12-14 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2022-12-14 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2023-01-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-12-19 |
| Cannula, Ear | JYC | Class 1 | General, Plastic Surgery | No | 2022-12-16 |
| Speculum, Illuminated | FXF | Class 1 | General, Plastic Surgery | No | 2025-09-25 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2022-12-01 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2025-09-26 |
| Splint, Endodontic Stabilizing | ELS | Class 2 | Dental | No | 2025-09-25 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2025-09-25 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2022-12-01 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2025-09-25 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | FAT | Class 2 | Gastroenterology, Urology | No | 2025-09-25 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2025-09-25 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2022-12-16 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2025-09-25 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2023-05-16 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2022-12-15 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2025-09-26 |
| Punch, Tonsil | KBT | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2022-12-19 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2022-12-05 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2022-12-15 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2022-12-01 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2022-12-15 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2022-12-05 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-12-15 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2022-12-01 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2025-09-25 |
| Handpiece (Brace), Drill | HBD | Class 1 | Neurology | No | 2025-09-26 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2022-11-30 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2023-01-23 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2022-12-15 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2025-09-26 |
| Bender | HXW | Class 1 | Orthopedic | No | 2023-01-23 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2022-12-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2022-12-15 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2022-12-19 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Trocar, Sinus | KBG | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-01-25 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2022-12-05 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2022-12-15 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-12-05 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2025-09-25 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2022-12-15 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2022-12-01 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2025-09-26 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2025-09-26 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2022-12-16 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2025-09-25 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2022-12-16 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2022-12-05 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2022-12-14 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2023-01-23 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2022-12-01 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2022-12-14 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2025-09-26 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2025-09-26 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2022-12-14 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2022-12-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2022-12-05 |
| Needle, Tumor Localization | MIJ | Class 1 | General, Plastic Surgery | No | 2025-09-26 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Spreader, Bladder Neck | FHK | Class 1 | Gastroenterology, Urology | No | 2025-09-25 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2025-09-26 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2022-12-05 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2023-01-23 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2025-09-25 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2022-12-05 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2022-12-05 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2022-12-07 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2025-09-25 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2022-12-13 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2022-12-14 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2022-12-15 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2025-09-26 |
Proprietary Names
N/A
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility