FDA Registration
Active
🇺🇸 United States
SHONEY SCIENTIFIC, INC.
Reg #: 2183650
·
FEI: 2183650
·
Expires 2026
Products
39
Proprietary Names
33
Establishment Types
1
Classifications
39
Registration Details
- Registration Name
- SHONEY SCIENTIFIC, INC.
- Registration Number
- 2183650
- FEI Number
- 2183650
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- WEST 223 NORTH 720 SARATOGA, DR., SUITE 120
- City
- WAUKESHA
- State
- WI
- ZIP
- 53186
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993463
Owner / Operator
- Firm Name
- SHONEY SCIENTIFIC, INC.
- Operator Number
- 2183650
- Address
- WEST 223 NORTH 720 SARATOGA, DR., SUITE 120
- City
- Waukesha
- State
- WI
- Postal Code
- 53186
- Country
- US
- Correspondent
- SANJAY S SHONEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2006-03-20 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2010-11-16 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1996-10-25 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-01-13 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2007-01-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-08-12 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2017-09-15 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2024-06-03 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2003-09-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-02-14 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-11-19 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-11-19 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2002-06-05 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 1996-10-25 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2007-10-29 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2004-11-16 |
| Bone Particle Collector | MXP | Class 1 | Ear, Nose, Throat | No | 2010-09-27 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2003-09-24 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2012-05-22 |
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2010-09-27 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2011-11-03 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2025-08-08 |
| Material, External Aesthetic Restoration, No Adhesive | NOK | Class 1 | General, Plastic Surgery | No | 2008-07-03 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2004-07-21 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2011-11-23 |
| Urinal | FNP | Class 1 | General Hospital | No | 2022-01-26 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2024-06-03 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2005-08-04 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2024-02-09 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2015-07-13 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2006-06-28 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2004-12-02 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2003-04-16 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-11-19 |
| Material, External Aesthetic Restoration, Used With Adhesive | GBI | Class 1 | General, Plastic Surgery | No | 2017-02-15 |
| Plastic Surgery And Accessories Kit | FTN | Class 1 | General, Plastic Surgery | No | 2010-11-16 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2003-08-21 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2003-09-24 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2003-04-23 |
Proprietary Names
McKesson Punch
Ear Well
IV Set
STETHOSCOPE-MONOSCOPE
Luer to Luer Connector
Others nonproprietary
IUD Remover
1Scope-HD Blade (Disposable)
IUD Insertion Kit
BPS Wrist Fracture Implants
Dennis Dilator - Gynex
Tru-Punch - Sklar
Gynex Keye's Punch
Brecise
Inno Infiltration Tubing
Disposable Osseous Bone Trap
No proprietary names
Suresample
AIROS 6P
Cache Nipple Shields
NA
AIROS 8P
#1 Urinal
Reinjection Tubing
PhemAlert - Gynex
Gynex Sims Sound
BPS Ankle Fracture Implants
Nipple Guard
Gynex Kevorkian Curette
Undies - Mentor
Others - NonProprietary
Elbow Immobilizer
Wrist Restrainer
Establishment Types
Repack or Relabel Medical Device