FDA Registration Active 🇺🇸 United States

NOVO SURGICAL, INC.

Reg #: 3008770252 · FEI: 3008770252 · Expires 2026
Products
298
Proprietary Names
9
Establishment Types
1
Classifications
298

Registration Details

Registration Name
NOVO SURGICAL, INC.
Registration Number
3008770252
FEI Number
3008770252
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
407 Plaza Drive
City
Westmont
State
IL
ZIP
60559
Country
US

Regulatory Submissions

510(k) Number
K974382

Owner / Operator

Firm Name
Novo Surgical Inc.
Operator Number
10034425
Address
407 Plaza Drive
City
Westmont
State
IL
Postal Code
60559
Country
US
Correspondent
Abed Moiduddin

Products

Device Name Product Code
Ring, Ophthalmic (Flieringa) HNH
Stripper, Vein, Reusable GAI
Pinwheel GWY
Probe HXB
Clamp, Ossicle Holding JYF
Scaler, Periodontic EMN
Needle, Ophthalmic Suturing HNM
Plier, Orthodontic JEX
Nipper, Malleus JYR
Carrier, Amalgam, Operative EKI
Hook, Gastro-Urology FHB
Trocar DRC
Crimper, Wire, Ent, Non-Sterile NNN
Laparoscope, General & Plastic Surgery GCJ
Saw, Manual And Accessories GDR
Twister, Wire HXS
Cutter, Wire HXZ
Burr, Corneal, Manual HOF
Tube, Ear Suction JZF
Retractor, Self-Retaining, For Neurosurgery GZT
Instrument, Surgical, Non-Powered HAO
Disinfectant, Medical Devices LRJ
Cystotome HNY
File, Surgical, General & Plastic Surgery GEO
Facebow KCR
Cannula, Ear JYC
Clamp, Vascular DXC
Curette, Surgical, General Use FZS
Stimulator, Muscle, Powered IPF
Stimulator, Muscle, Powered, For Muscle Conditioning NGX
Gauge, Lens, Ophthalmic HLN
Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Sound, Urethral, Metal Or Plastic FBX
Probe, Ent KAK
Accessories, Retractor, Dental EIF
Clip, Aneurysm HCH
Holder, Needle; Orthopedic HXK
Ring Cutter FNS
Chisel, Osteotome, Surgical EMM
Knife, Surgical EMF
Brace, Drill HXY
Scissors, Nasal KBD
Needle, Aspiration And Injection, Reusable GDM
Retractor, Vaginal HDL
Forceps HTD
Tourniquet, Nonpneumatic GAX
Cannula, Ophthalmic HMX
Specula Accessories FXG
Retractor, Fiberoptic FDG
Osteotome HWM
Elevator, Ent KAD
Cannula, Manipulator/Injector, Uterine LKF
Bougie, Urological FAX
Forceps, Obstetrical HDA
Ligator, Hemorrhoidal FHN
Spatula, Orthopedic HXR
Rasp, Ear JYY
Speculum, Vaginal, Metal HDF
Dilator, Rectal FFP
Clip, Scalp HBO
Forceps, Ophthalmic HNR
Surgical Instruments, G-U, Manual (And Accessories) KOA
Forceps, Disconnect FJR
Marker, Ocular HMR
Brush, Scrub, Operating-Room GEC
Snare, Nasal KBE
Reamer HTO
Clamp, Penile FHA
Irrigator, Sinus KAR
Stripper, Surgical HRT
Saw, Nasal KBC
Splint, Hand, And Components ILH
Introducer, Sphere HNP
Probe, Lachrymal HNL
Pelvimeter, External HER
Electrosurgical, Cutting & Coagulation & Accessories GEI
Retractor, Self-Retaining FFO
Forceps, Biopsy, Non-Electric FCL
Pliers, Operative EJY
Cleaner, Ultrasonic, Medical Instrument FLG
Catheter And Tip, Suction JOL
Knife, Ear JYO
Passer HWQ
Handle, Instrument, Dental EJB
Instrument, Microsurgical GZX
Retractor, All Types EIG
Impactor HWA
Knife, Ent KTG
Dilator, Tracheal KCG
Excavator, Dental, Operative EKC
Component, Traction, Non-Invasive KQZ
Instrument, Filling, Plastic, Dental EIY
Urethrotome EZO
Instrument, Cutting, Orthopedic HTZ
Dilator, Esophageal, Ent KCF
Device, Fixation, Tracheal Tube CBH
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Blade, Saw, General & Plastic Surgery, Surgical GFA
Curette, Nasal KAP
Snare, Ear JZD
Curette, Ethmoid KAO
Rongeur HTX
Stylet, Surgical, General & Plastic Surgery GAH
Specula, Ophthalmic HNC
Device, Irrigation, Ocular Surgery KYG
Awl HWJ
Accessories, Arthroscopic NBH
Syringe, Ent KCP
Rongeur, Nasal KBB
Curette, Adenoid KBJ
Clamp, Non-Electrical FFN
Curette, Uterine HCY
Mobilizer, Ent KAJ
Scissors, Ear JZB
Hammer, Surgical FZY
Corkscrew HWI
Basin, Emesis FNY
Curette, Surgical, Dental EMK
Depressor, Orbital HNX
Caliper, Ophthalmic HOE
Skid, Bone HWO
Laryngoscope, Rigid CCW
Trocar, Ent KTE
Knife, Nasal KAS
Mirror, Ent KAI
Cannula, Ventricular HCD
Punch, Ent KTF
Chisel, Surgical, Manual FZO
Knife, Ophthalmic HNN
Gag, Mouth KBN
Dilator, Vessel, Surgical DWP
Hemostat HRQ
Cutter, Surgical FZT
Punch, Corneo-Scleral HNJ
Chisel, Middle-Ear JYE
Depressor, Metal Tongue, Surgical KBL
Curette HTF
Retractor GAD
Probe, Periodontic EIX
Trephine, Manual, Ophthalmic HRH
Guide, Surgical, Instrument FZX
Speculum, Non-Illuminated FXE
Chisel, Bone, Surgical EML
Instrument, Cast Application/Removal, Manual LGG
Cannula And Trocar, Suprapubic, Non-Disposable FBM
Retractor, Ent KAL
Goniometer, Nonpowered KQW
Source, Carrier, Fiberoptic Light EQH
Bit, Drill HTW
Saw HSO
Scissors, Wire Cutting, Ent, Non-Sterile NNU
Block, Cutting, Ent, Non-Sterile NNR
Elevator, Surgical, General & Plastic Surgery GEG
Passer, Wire, Orthopedic HXI
Pick, Massaging JET
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Forceps, Rongeur, Surgical EMH
Excavator, Ear JYH
Burr, Corneal, Battery Powered, Rust Ring Removal OHW
Packer, Uterine HDM
Curette, Ophthalmic HNZ
Probe And Director, Gastro-Urology FGM
Scoop FHL
Loop, Wire JYQ
Spud, Ophthalmic HNA
Burr, Orthopedic HTT
Mirror, General & Plastic Surgery FTX
Scissors, Collar And Crown EIR
Applicator, Ent KCJ
Hook, Microsurgical Ear JYL
Dam, Rubber EIE
Dilator, Lachrymal HNW
Scissors, Orthopedic, Surgical HRR
Rasp, Nasal KBA
Scissors, General, Surgical LRW
Rod, Measuring Ear JYZ
Scissors, Ophthalmic HNF
Osteotome, Manual GFI
Elevator, Surgical, Dental EMJ
Clip, Removable (Skin) FZQ
Clamp, Rubber Dam EEF
Spatula, Surgical, General & Plastic Surgery GAF
Holder, Ear Speculum JYK
Pliers, Surgical HTC
Forceps, Tooth Extractor, Surgical EMG
Hand, External Limb Component, Mechanical IRA
Spoon, Ophthalmic HNB
Fork, Tuning GWX
Needle, Tonsil Suturing KBR
Clamp, Eyelid, Ophthalmic HOD
Gauge, Depth HTJ
Tourniquet, Gastro-Urology EYR
Dermatome GFD
Probe, Rectal, Non-Powered EXX
Explorer, Operative EKB
Tray, Surgical LRP
Forceps, Rubber Dam Clamp EJG
Mirror, Mouth EAX
Gauge, Depth, Instrument, Dental EIL
Forceps, Ent KAE
Caliper KTZ
Dilator, Cervical, Fixed Size HDQ
Chisel (Osteotome) KDG
Dilator, Catheter GCC
Holder, Needle, Gastroenterologic FHQ
Tape, Measuring, Rulers And Calipers FTY
Plugger, Root Canal, Endodontic EKR
Adenotome KBH
Clamp, Surgical, General & Plastic Surgery GDJ
Instrument, Ent Manual Surgical LRC
Gauge, Measuring JYJ
Hook, Ophthalmic HNQ
Rasp HTR
Retractor, Ophthalmic HNI
Snare, Enucleating HNE
File, Bone, Surgical EMI
Trephine HWK
Forceps, Tube Introduction BWB
Stylet, Ureteral EYA
Punch, Adenoid KBS
Punch, Biopsy, Surgical EME
Handpiece (Brace), Drill HBD
Speculum, Rectal FFQ
Burnisher, Operative EKJ
Punch, Surgical LRY
Scissors, Episiotomy HDK
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal MXY
Hook, Fibroid, Gynecological HDE
Carver, Dental Amalgam, Operative EKH
Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
Applier, Hemostatic Clip HBT
Punch, Antrum KAW
Probe, Trabeculotomy HNK
Chisel, Nasal KAN
Handle, Scalpel GDZ
Forceps, Dressing, Dental EFL
Needle, Suturing, Reusable GDL
Scissors, Medical, Disposable JOK
Knife, Orthopedic HTS
Orthopedic Manual Surgical Instrument LXH
Curette, Ear JYG
Cannula, Surgical, General & Plastic Surgery GEA
Applier, Surgical, Clip GDO
Needle, Biopsy, Cardiovascular DWO
Instrument, Ligature Tucking, Orthodontic ECP
Sound, Uterine HHM
Instruments, Surgical, Cardiovascular DWS
Support, Patient Position CCX
Marker, Skin FZZ
Retractor, Non-Self-Retaining FGN
Tray, Surgical, Instrument FSM
Gouge, Surgical, General & Plastic Surgery GDH
Mallet, Surgical, General & Plastic Surgery GFJ
Knife, Laryngeal JZY
Clamp, Uterine HGC
Blade, Scalpel GES
Curette, Periodontic EMS
Instrument, Ligature Passing And Knot Tying HCF
Syringe, Irrigating (Dental) EIB
Hook, Bone KIK
Snare, Tonsil KBZ
Pick, Microsurgical Ear JYT
Forceps, General & Plastic Surgery GEN
Elevator HTE
Carver, Wax, Dental EIK
Knife, Myringotomy JYP
Gouge, Nasal, Ent KAQ
Instrument, Manual, General Obstetric-Gynecologic KOH
Speculum, Ent EPY
Tube, Tonsil Suction KCB
Accessories, Cleaning Brushes, For Endoscope MNL
Hook, Surgical, General & Plastic Surgery GDG
Clamp HXD
Knife, Amputation GDN
Dissector, Surgical, General & Plastic Surgery GDI
Forceps, Wire Holding HYA
Instrument, Manual, Surgical, General Use MDM
Rasp, Surgical, General & Plastic Surgery GAC
Forceps, Biopsy, Gynecological HFB
Marker, Sclera HMQ
Snare, Non-Electrical FGX
Scissors, Surgical Tissue, Dental EGN
Curette, Operative EKE
Hook, Tracheal KCH
Tonometer, Manual HKY
File, Periodontic EMR
Clip, Implantable FZP
Clip, Hemostatic MCH
File HTP
Tamp HXG
Mallet HXL
Tube, Laryngectomy KAC
Spatula, Ophthalmic HND
Knife, Tonsil KBQ
Bur, Surgical, General & Plastic Surgery GFF
Scissors, Umbilical HDJ
Carrier, Ligature GEJ

Proprietary Names

PowerDot(R) PD-01M2 Muscle Stimulator (with PowerDot (R) Mobile Application) Novo Dental Retractor Accessories Novo Surgical Retractor, All Types Novo Surgical Speculum, Non-Illuminated Novo Surgical Forceps, Tooth Extractor, Surgical Novo Surgical Forceps, Ent Novo Surgical Holder, Needle, Gastroenterologic Novo Surgical Forceps, Dressing, Dental Novo Surgical Sound, Uterine

Establishment Types

Repack or Relabel Medical Device