BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AESCULAP, INC.

    Reg #: 2916714 · FEI: 2916714 · Expires 2026
    View on FDA
    Products
    318
    Proprietary Names
    51
    Establishment Types
    2
    Classifications
    318

    Registration Details

    Registration Name
    AESCULAP, INC.
    Registration Number
    2916714
    FEI Number
    2916714
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3773 CORPORATE PKWY.
    City
    CENTER VALLEY
    State
    PA
    ZIP
    18034
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172850

    Owner / Operator

    Firm Name
    AESCULAP, INC.
    Operator Number
    2916714
    Address
    3773 CORPORATE PKWY., --
    City
    Center Valley
    State
    PA
    Postal Code
    18034
    Country
    US
    Correspondent
    Kamaal Anas

    Products

    Device Name Product Code
    Forceps, Obstetrical HDA
    Depressor, Orbital HNX
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Laparoscope, General & Plastic Surgery GCJ
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Retractor, Self-Retaining, For Neurosurgery GZT
    Arthroscope HRX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Curette, Ear JYG
    Applier, Aneurysm Clip HCI
    Forceps, Rubber Dam Clamp EJG
    Applier, Surgical, Clip GDO
    Clip, Vascular DSS
    Clip, Implantable FZP
    Clip, Scalp HBO
    Retractor, Vaginal HDL
    Catheter, Eustachian, General & Plastic Surgery GBY
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Operating Room Accessories Table Tray FWZ
    Knife, Amputation GDN
    Condenser, Amalgam And Foil, Operative EKG
    Corkscrew HWI
    Holder, Needle; Orthopedic HXK
    Instrument, Manual, Surgical, General Use MDM
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Explorer, Operative EKB
    Cannula, Manipulator/Injector, Uterine LKF
    Forceps, Wire Holding HYA
    Forceps, Surgical, Gynecological HCZ
    Dura Substitute GXQ
    Rod, Measuring Ear JYZ
    Forceps, Ophthalmic HNR
    Knife, Ent KTG
    Plate, Cranioplasty, Preformed, Alterable GWO
    Polymer, Ent Synthetic, Porous Polyethylene JOF
    Headrest, Neurosurgical HBM
    Dilator, Esophageal (Metal Olive) Gastro-Urology EZM
    Needle, Ophthalmic Suturing HNM
    Indicator, Physical/Chemical Sterilization Process JOJ
    Punch, Nasal KAY
    Instrument, Microsurgical GZX
    Device, Locking, For Intestinal Clamp FFR
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Shunt, Central Nervous System And Components JXG
    Tap, Bone HWX
    Chisel, Middle-Ear JYE
    Curette, Uterine HCY
    Tonsillectome KCA
    Scissors, Umbilical HDJ
    Brace, Drill HXY
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Needle, Suturing, Reusable GDL
    Instrument, Ligature Passing And Knot Tying HCF
    Holder, Camera, Surgical FXR
    Wrap, Sterilization FRG
    Forceps, General & Plastic Surgery GEN
    Pelvimeter, External HER
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Guide, Surgical, Instrument FZX
    Knife, Nasal KAS
    Cannula And Trocar, Suprapubic, Non-Disposable FBM
    Depressor, Metal Tongue, Surgical KBL
    Probe, Rectal, Non-Powered EXX
    Punch, Adenoid KBS
    Holder, Needle, Gastroenterologic FHQ
    Rasp HTR
    Scaler, Periodontic EMN
    Clip, Aneurysm HCH
    Drape, Surgical, Exempt PUI
    Curette, Adenoid KBJ
    Stripper, Surgical HRT
    Wrench HXC
    Amniotome HGE
    Mirror, Ent KAI
    Gag, Mouth KBN
    Clamp, Surgical, General & Plastic Surgery GDJ
    Introducer, Sphere HNP
    Cutter, Surgical FZT
    Tray, Impression, Preformed EHY
    Elevator, Surgical, Dental EMJ
    Rongeur, Nasal KBB
    Block, Cutting, Ent, Non-Sterile NNR
    Knife, Ophthalmic HNN
    Plugger, Root Canal, Endodontic EKR
    Plate, Bone JEY
    Cover, Burr Hole GXR
    Fastener, Plate, Cranioplasty HBW
    Needle, Dental DZM
    Antisera, All Leptospira Spp. GRX
    Tray, Surgical, Instrument FSM
    Retractor, Ent KAL
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Carrier, Amalgam, Operative EKI
    Knife, Laryngeal JZY
    Clamp, Uterine HGC
    Accessories, Retractor, Dental EIF
    Blade, Scalpel GES
    Hook, Ophthalmic HNQ
    Curette, Ophthalmic HNZ
    Chisel (Osteotome) KDG
    Clamp, Vascular DXC
    Retractor, Self-Retaining FFO
    Chisel, Bone, Surgical EML
    Table, Operating-Room, Manual FSE
    Instrument, Bending Or Contouring HXP
    Ring, Ophthalmic (Flieringa) HNH
    Needle, Aspiration And Injection, Reusable GDM
    Instrument, Contouring, Matrix, Operative EKF
    Dermatome GFD
    Snare, Tonsil KBZ
    Excavator, Dental, Operative EKC
    Retractor, Ophthalmic HNI
    Instrument, Surgical, Non-Powered HAO
    Speculum, Rectal FFQ
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Rasp, Ear JYY
    Elevator, Surgical, General & Plastic Surgery GEG
    Nipper, Malleus JYR
    Forceps, Articulation Paper EFK
    Instrument, Ligature Tucking, Orthodontic ECP
    Clamp, Wire, Orthodontic ECN
    Light, Surgical, Floor Standing FSS
    Endoscope, Neurological GWG
    Scrapper, Skin Specimen LXK
    Unit, Suction Operatory EBR
    Motor, Drill, Electric HBC
    Motor, Surgical Instrument, Ac-Powered GEY
    Spatula, Surgical, General & Plastic Surgery GAF
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Instruments, Dental Hand DZN
    Irrigator, Sinus KAR
    Retractor, All Types EIG
    Probe, Periodontic EIX
    Retainer, Matrix JEP
    Rongeur, Powered HAD
    Bottle, Collection, Vacuum KDQ
    Laparoscope, Gynecologic (And Accessories) HET
    Container, Specimen, Non-Sterile NNI
    Elevator, Ent KAD
    Stripper, Vein, Reusable GAI
    Tape, Measuring, Rulers And Calipers FTY
    Mallet, Surgical, General & Plastic Surgery GFJ
    Dilator, Cervical, Fixed Size HDQ
    Hook, Bone KIK
    Wire, Orthodontic DZC
    Hammer, Surgical FZY
    System, X-Ray, Angiographic IZI
    Needle, Tonsil Suturing KBR
    Depressor, Tongue, Non-Surgical FMA
    Gouge, Surgical, General & Plastic Surgery GDH
    Probe, Ent KAK
    Scissors, Wire Cutting, Ent, Sterile JYA
    Countersink HWW
    Punch, Ent KTF
    Instrument, Clip Removal HBQ
    Instrument, Filling, Plastic, Dental EIY
    Speculum, Ent EPY
    Dilator, Lachrymal HNW
    Adenotome KBH
    Carver, Dental Amalgam, Operative EKH
    Hemostat HRQ
    Saw, Nasal KBC
    Scissors, Ear JZB
    Blade, Saw, Surgical, Cardiovascular DWH
    Dilator, Nasal LWF
    Loop, Wire JYQ
    Osteotome, Manual GFI
    Hook, Tracheal KCH
    Osteotome HWM
    Mallet HXL
    Extractor HWB
    Dilator, Vessel, Surgical DWP
    Clamp, Umbilical HFW
    Curette, Nasal KAP
    Scissors, Episiotomy HDK
    Gauge, Depth HTJ
    Dilator, Esophageal, Ent KCF
    Retractor, Non-Self-Retaining FGN
    Laparoscopic Accessories, Gynecologic NWV
    Tubing, Noninvasive GAZ
    Cannula, Ventricular HCD
    Mirror, General & Plastic Surgery FTX
    Forceps, Biopsy, Gynecological HFB
    Probe HXB
    Pliers, Operative EJY
    Microscope, Surgical, General & Plastic Surgery FSO
    Pneumoperitoneum Needle FHO
    Insufflator, Laparoscopic HIF
    Sound, Urethral, Metal Or Plastic FBX
    Instrument, Cast Application/Removal, Manual LGG
    Orthopedic Manual Surgical Instrument LXH
    Excavator, Ear JYH
    Elevator HTE
    Clamp, Penile FHA
    Ligator, Hemorrhoidal FHN
    Loupe, Diagnostic/Surgical FSP
    Instrument, Manual, Specialized Obstetric-Gynecologic KNA
    Awl HWJ
    Probe And Director, Gastro-Urology FGM
    Infusor, Pressure, For I.V. Bags KZD
    Rongeur, Manual HAE
    Burnisher, Operative EKJ
    Dilator, Rectal FFP
    Scissors, Nasal KBD
    Passer HWQ
    Burr, Orthopedic HTT
    Handle, Scalpel GDZ
    Electrocautery, Gynecologic (And Accessories) HGI
    Saw, Manual And Accessories GDR
    Punch, Antrum KAW
    Impactor HWA
    Tube, Ear Suction JZF
    Rasp, Nasal KBA
    Instruments, Surgical, Cardiovascular DWS
    Snare, Nasal KBE
    Punch, Surgical LRY
    Dissector, Tonsil KBM
    Clamp, Circumcision HFX
    Tamp HXG
    Clamp, Non-Electrical FFN
    Knife, Orthopedic HTS
    Forceps HTD
    Accessories, Catheter KGZ
    Sterilizer, Steam FLE
    Hook, Surgical, General & Plastic Surgery GDG
    Mirror, Mouth EAX
    Chisel, Osteotome, Surgical EMM
    Dissector, Surgical, General & Plastic Surgery GDI
    Rongeur HTX
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Forceps, Rongeur, Surgical EMH
    Motor, Surgical Instrument, Pneumatic Powered GET
    File HTP
    Applicator, Ent KCJ
    Curette, Surgical, Dental EMK
    Anoscope And Accessories FER
    Clip, Removable (Skin) FZQ
    Curette, Surgical, General Use FZS
    Punch, Tonsil KBT
    Snare, Ear JZD
    Motor, Drill, Pneumatic HBB
    Carver, Wax, Dental EIK
    Expander, Surgical, Skin Graft FZW
    Retractor GAD
    Saw, Powered, And Accessories HAB
    Forceps, Dressing, Dental EFL
    Bone Mill LYS
    Remover, Crown EIS
    Fork, Tuning GWX
    Trocar, Gastro-Urology FBQ
    Clamp HXD
    Knife, Surgical EMF
    File, Bone, Surgical EMI
    Accessories, Arthroscopic NBH
    Table, Operating-Room, Electrical GDC
    Camera, Surgical And Accessories KQM
    Trocar, Ent KTE
    Forceps, Ent KAE
    System, Evacuator, Fluid FHF
    Clamp, Ossicle Holding JYF
    Scoop FHL
    Forceps, Tooth Extractor, Surgical EMG
    Knife, Periodontic EMO
    Pick, Microsurgical Ear JYT
    Spud, Ophthalmic HNA
    Bougie, Urological FAX
    Plier, Orthodontic JEX
    Cannula, Ophthalmic HMX
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Hook, Microsurgical Ear JYL
    Spatula, Ophthalmic HND
    Twister, Wire HXS
    Catheter, Ventricular HCA
    Instrument, Ent Manual Surgical LRC
    Goniometer, Nonpowered KQW
    Percussor GWZ
    Device, Monitoring, Intracranial Pressure GWM
    Drape, Surgical, Antimicrobial KKX
    Scissors, General, Surgical LRW
    Knife, Tonsil KBQ
    Bur, Surgical, General & Plastic Surgery GFF
    Scissors, Orthopedic, Surgical HRR
    Bit, Drill HTW
    Ring, Laparotomy FHI
    Instrument, Cutting, Orthopedic HTZ
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Speculum, Vaginal, Metal HDF
    Caliper KTZ
    Scissors, Collar And Crown EIR
    Applier, Staple, Surgical, GEF
    Scissors, Ophthalmic HNF
    Rasp, Surgical, General & Plastic Surgery GAC
    Cutter, Wire HXZ
    Source, Carrier, Fiberoptic Light EQH
    Device, Digital Image Storage, Radiological LMB
    Hoe, Periodontic EMQ
    Specula, Ophthalmic HNC
    Knife, Ear JYO
    Probe, Lachrymal HNL
    Perforator, Antrum KAT
    Bender HXW
    Caliper, Ophthalmic HOE
    Instrument, Shunt System Implantation GYK
    Stabilizer, Heart MWS
    Catheter, Irrigation GBX
    Marker, Skin FZZ
    Chisel, Nasal KAN
    Illuminator, Fiberoptic, Surgical Field HBI
    Image, Illumination, Fiberoptic, For Endoscope FFS
    Screwdriver HXX
    Sound, Uterine HHM
    Battery, Replacement, Rechargeable MOQ
    Chisel, Surgical, Manual FZO
    Pliers, Surgical HTC
    Knife, Myringotomy JYP
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Scissors, Surgical Tissue, Dental EGN
    Applier, Hemostatic Clip HBT

    Proprietary Names

    Aesculap RETRACTOR RICHARDSON APPENDS MANUAL OPERATING TABLE CHAIR AND ACCESSORIES AESCULAP GRASPER DENTAL HAND INSTRUMENT FORCEPS ENT EAR NOSE AND THROAT ORTHOPEDIC TTACHMENT ,AC-POWERED MOTOR AND ACCESSORY SURGICAL CAMERA AND ACCESSORIES KERRISON RONGEUR CARVABLE SILICON BLOCK VARIOIUS DENTAL RETRACTOR ACCESSORIES aesculap SUCTION UNIT ATTACHMENTS HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE VACUUM-POWERED BODY F DENTAL INSTRUMENT BONE HOOK PROSPACE BONE ALIF STERNUM SAW BLADE AESCULAP Prestige OBSTETRIC-GYNECOLOGIC SPE PRESSURE INFUSOR FOR AN I.V. BAG OSTEOTOME ATTACHMENT CHMENT RETRACTOR ARTHROSCOPIC ACCESSORIES SINOSCOPY TROCAR NOSE AND THROAT MANUAL SURGICAL INS TRUMENT EAR HILAN ET AL MANUAL GATROENTEROLOGY-UROLOGY SU CARRIER FIBEROPTIC LIGHT SOURCE SKIN MARKER BALLINGER CHISEL MANUAL GASTROENTEROLOGY-UROLOGY S

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility