FDA Registration
Active
🇺🇸 United States
FETZER SURGICAL, LLC
Reg #: 3010687973
·
FEI: 3010687973
·
Expires 2026
Products
125
Proprietary Names
1
Establishment Types
2
Classifications
125
Registration Details
- Registration Name
- FETZER SURGICAL, LLC
- Registration Number
- 3010687973
- FEI Number
- 3010687973
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9217 E. Verde Grove Vw.
- City
- Scottsdale
- State
- AZ
- ZIP
- 85255
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163524
Owner / Operator
- Firm Name
- Fetzer Surgical, LLC
- Operator Number
- 10046280
- Address
- 9217 E VERDE GROVE VW.
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85255
- Country
- US
- Correspondent
- Chad Fetzer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2018-11-28 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2019-10-15 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2018-11-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-11-29 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2018-11-29 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2021-03-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2021-06-18 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2018-11-28 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2021-02-22 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2019-10-15 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2018-11-28 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2014-02-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-10-15 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2018-11-29 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2014-02-28 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2021-02-22 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2018-11-29 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2018-11-28 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Probe | HXB | Class 1 | Orthopedic | No | 2018-11-29 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2018-11-28 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2019-10-15 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2014-02-27 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2019-10-15 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2018-11-29 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2022-03-04 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2019-10-15 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2018-11-28 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2021-06-24 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2014-02-28 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2018-11-29 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2014-02-28 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 2018-11-29 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2018-11-28 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2019-10-15 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2014-02-28 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2021-06-24 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2018-11-29 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2014-02-28 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-02-22 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2014-02-28 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2018-11-29 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2014-02-28 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2021-06-25 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2018-11-29 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2019-10-15 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-05-16 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2014-02-28 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2014-02-28 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2018-11-28 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2018-11-28 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2018-11-29 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2018-11-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2014-02-27 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2018-11-28 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2018-11-29 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2018-11-29 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2014-02-28 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2019-10-15 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2021-02-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-11-29 |
| Crimper, Wire, Ent, Non-Sterile | NNN | Class 1 | Ear, Nose, Throat | No | 2021-06-24 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2018-11-28 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2023-12-08 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2018-11-28 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2018-11-28 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2014-02-27 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2014-02-28 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2018-11-29 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2018-11-29 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2018-11-29 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2018-11-28 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2021-06-24 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2021-06-23 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2018-11-28 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2021-02-22 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2014-02-28 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2021-06-24 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2018-11-28 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2018-11-28 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2019-10-15 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2018-11-29 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2014-02-28 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2019-10-15 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2014-02-28 |
| Percussor | GWZ | Class 1 | Neurology | No | 2018-11-28 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2014-02-28 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2014-02-28 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2018-11-28 |
Proprietary Names
Cannula, Subprapubic
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility