Sklar Corporation

FDA Device Registration & Listing · West Chester, PA, US · Registration 2431166

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2431166
FEI Number
2523865
Entity Name
Sklar Corporation
City/State/Country
West Chester, PA, US
Establishment Address
1333 Lenape Rd., West Chester, PA 19382, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Sklar Corporation (Owner Number: 10023634)
Owner / Operator Contact Address
1333 Lenape Rd., West Chester, PA 19382, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sklar Instruments Rasp Uterine Sound Gauge File Retractor Sklar Instruments Tip Protector Cannula, Perfusion, Fallopian Tube Scissor Scissor Probe Dermatoscope Impression Tray Brushes Eyeshield Toothbrush Handle Saw Retractor Thorek Scissors 7.25 & 10" Remover Carrier Wire Cutting Plier Knife Trocar Curette Chisel brushes Matrix Band Chisel Gouge Spatula Clip Cuff Corneal Trephine Biopsy Forceps Needle Holder Excavator needle Skull Punch cutter Sterile Bowl Recloseable Bag Curette Plier Plier Twister ENT Punch Forceps Bougie Curette Amputation Knife Kirschner Wire/Steinmann Pin Applier Clamp Knife Cardiovascular I.D. Roll Tape Articulators OBSTETRICAL FORCEPS Dilator Handle Needle Blade Miniclamps, Stabiliz, Fallopian Tub Rasp Sklar Sklar Cutter, Surgical Sklar Cutter Hook Wrap Hemorrhoidal Ligator curette Probe curette Suction Tube Sklar Amniocentesis Tray Scissors, Iris Sklar Instruments Dissector Extractor Carver Curette Cannula, Perfusion, Fallo Magill Catheter Intro. Forceps Mouth Mirror Sklar Instruments Curette Arthroscopic Accessories Osteotome Scissor Sklar Scrub Brush Trays Sklar General Surgical Gown Rasp Applier Band Setter Rudd-Clinic Hermorrhoidal Forceps Burnisher Sklar Instruments Probe and Director Retractor Plier Spatula Cannula Sklar Pencils Penis Clamp Scissors Trach Tube Knife Dilator Ring Cutter punch Spoon Cast Spreader Screwdriver Scaler Laryngoscope Pick Bowl Trays Rongeur Hook Scissors, Strabimus 4" Str Suction Tube Sterile Indicator trach tube Sccissors, Strabismus 4" Curved Probe Elevator Stripper Ear Knife, Politzer Kevorkian-Young Biopsy Curette Sklar Instruments Crown Remover Carver Specula Caliper Saw Forceps Sklar Instruments Sklar Gauze and Ligature Director Biopsy Punch Gag Adenoid Curette File Gusberg Hysterectomy Hook

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2008-12-17
HTR Rasp General, Plastic Surgery Class 1 878.4800 2017-10-11
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2024-01-11
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-12-11
EMR File, Periodontic Dental Class 1 872.4565 2019-05-14
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-15
HTD Forceps General, Plastic Surgery Class 1 878.4800 2008-12-17
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2022-03-16
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2007-12-06
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2018-03-19
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2018-03-19
HXB Probe Orthopedic Class 1 888.4540 2017-10-11
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2020-09-09
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2018-11-13
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2016-06-29
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2019-05-14
EFW Toothbrush, Manual Dental Class 1 872.6855 2016-06-29
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2019-05-14
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2018-11-13
EIG Retractor, All Types Dental Class 1 872.4565 2022-12-29
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-12-06
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2019-05-14
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2019-05-14
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2022-12-29
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2018-12-11
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2018-03-19
EKE Curette, Operative Dental Class 1 872.4565 2018-11-13
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2019-05-14
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2016-06-29
JEP Retainer, Matrix Dental Class 1 872.4565 2023-12-13
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-03-19
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-03-19
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-19
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2018-12-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2017-02-10
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2024-07-25
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2024-08-16
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2022-08-16
EKC Excavator, Dental, Operative Dental Class 1 872.4565 2023-12-13
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2013-05-10
GXJ Punch, Skull Neurology Class 1 882.4750 2018-07-20
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2013-05-10
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-07-03
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-16
EJY Pliers, Operative Dental Class 1 872.4565 2018-12-11
FJY Plier, Crimp Gastroenterology, Urology Class 1 876.5540 2018-12-11
HXS Twister, Wire Orthopedic Class 1 888.4540 2017-10-11
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2024-02-02
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-16
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2019-11-19
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2018-07-20
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2018-11-13
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2017-12-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-20
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2018-11-13
HFX Clamp, Circumcision Obstetrics/Gynecology Class 2 884.4530 2016-08-09
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2018-12-11
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2018-11-13
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2022-03-16
EJP Articulators Dental Class 1 872.3150 2024-01-11
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2016-08-09
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2018-11-13
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2018-03-19
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2017-10-17
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2018-11-13
HCZ Forceps, Surgical, Gynecological Obstetrics/Gynecology Class 2 884.4530 2007-12-06
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-11-13
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2015-04-01
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2015-06-02
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-12-06
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2015-04-01
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2018-12-11
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2018-12-11
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2016-08-09
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2007-12-06
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-05-10
EIX Probe, Periodontic Dental Class 1 872.4565 2019-05-14
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2013-05-10
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2024-01-11
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2008-02-05
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-12-06
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2018-07-19
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2018-11-13
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 2018-03-19
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2018-03-19
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2013-05-10
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-12-06
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2007-12-06
EAX Mirror, Mouth Dental Class 1 872.4565 2018-07-20
FTN Plastic Surgery And Accessories Kit General, Plastic Surgery Class 1 878.3925 2008-12-17
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2018-03-23
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2023-12-11
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2018-07-20
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2016-06-30
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-04-01
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2016-06-29
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-08-09
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2009-11-10
KBI Bougie, Eustachian Ear, Nose, Throat Class 1 874.4175 2019-05-14
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2019-05-14
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 2024-01-03
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2007-12-06
EKJ Burnisher, Operative Dental Class 1 872.4565 2023-12-13
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2008-12-17
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2018-03-23
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-03-16
JEX Plier, Orthodontic Dental Class 1 872.4565 2018-12-11
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2017-06-19
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-19
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-05-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-10
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2023-12-13
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 2022-08-16
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2017-09-05
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2023-12-11
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2017-02-10
FNS Ring Cutter General Hospital Class 1 880.6200 2018-03-19
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2013-05-10
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2018-12-11
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2018-03-19
HXX Screwdriver Orthopedic Class 1 888.4540 2018-12-11
EMN Scaler, Periodontic Dental Class 1 872.4565 2018-03-19
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2018-11-13
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2018-11-13
FNY Basin, Emesis General Hospital Class 1 880.6730 2024-07-03
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-08-09
HTX Rongeur Orthopedic Class 1 888.4540 2018-03-16
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2018-12-11
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-12-06
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2022-02-03
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2017-06-19
EPE Brush, Cleaning, Tracheal Tube Anesthesiology Class 1 868.5795 2016-06-29
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-12-06
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2018-11-13
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2018-03-19
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2018-07-20
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2007-12-05
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2007-12-06
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2008-12-17
EIS Remover, Crown Dental Class 1 872.4565 2024-01-11
EIK Carver, Wax, Dental Dental Class 1 872.4565 2018-11-13
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2018-11-13
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-23
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2021-03-22
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2019-05-14
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2008-12-17
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2015-05-13
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2022-12-29
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2007-12-06
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2018-03-15
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2018-11-13
EMI File, Bone, Surgical Dental Class 1 872.4565 2018-03-15
HGC Clamp, Uterine Obstetrics/Gynecology Class 1 884.4520 2007-12-06
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2018-12-11

Official Correspondent

Debasish Ghosh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sklar Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015895045 Sklar Corporation - Warehouse Salisbury, MD, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K821275 Conphar, Inc. MAYO SCISSOR STRAIGHT 5 1/2 1982-05-28
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K831136 Almore Intl., Inc. DOUBLE BOW TOOTH SEPARATOR 1983-06-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number Establishment Name Location
3004571672 Fischer Surgical Inc. Imperial, MO, US
3015895045 Sklar Corporation - Warehouse Salisbury, MD, US
3009718267 DIVERSITY CORPORATION FZE Sharjah Ash Shariqah, AE
3013784566 Berger Surgical Medical Products GmbH Neuhausen ob Eck Baden-Wurttemberg, DE
3004168759 CENTRAL SURGICAL CO. PVT. LTD. Sialkot Punjab, PK
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2431166. Last updated year: 2026. Please use registration number 2431166 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.