BOSS INSTRUMENTS, LTD.

FDA Device Registration & Listing · Gordonsville, VA, US · Registration 1056350

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
1056350
FEI Number
1000140363
Entity Name
BOSS INSTRUMENTS, LTD.
City/State/Country
Gordonsville, VA, US
Establishment Address
104 Sommerfield Drive, Gordonsville, VA 22942, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
BOSS INSTRUMENTS, LTD. (Owner Number: 9005081)
Owner / Operator Contact Address
104 Sommerfield Drive, --, Gordonsville, VA 22942, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BOSS BOSS Boss Obstetrical Forceps BOSS dental rongeur BOSS BOSS BOSS Tracheal Dilator BOSS BOSS BOSS Boss Mirror BOSS Endodontic Curette BOSS BOSS BOSS BOSS bone chisel BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS Curette BOSS BOSS BOSS BOSS BOSS BOSS BOSS Lacrimal Probe BOSS BOSS BOSS BOSS BOSS Bone Hook BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS dermal punch BOSS BOSS BOSS BOSS BOSS BOSS Amputation Knife Osteotome BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS BOSS uterine clamp BOSS BOSS BOSS BOSS BOS BOSS BOSS Reverdin Needle BOSS BOSS General Instrument Tray BOSS BOSS BOSS BOSS BOSS BOSS Boss Dental Retractors BOSS surgical clamp BOSS BOSS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2009-05-11
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2019-01-10
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2010-11-05
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2014-11-10
HAE Rongeur, Manual Neurology Class 2 882.4840 2008-08-19
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 2008-11-07
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2014-11-10
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2019-03-27
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2019-03-27
HTW Bit, Drill Orthopedic Class 1 888.4540 2008-11-07
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2016-09-21
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2008-11-07
EAX Mirror, Mouth Dental Class 1 872.4565 2019-03-27
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 1998-02-04
EKT Curette, Endodontic Dental Class 1 872.4565 2014-11-10
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2011-06-18
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 1998-02-04
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2008-11-07
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2008-11-07
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2014-11-10
HXD Clamp General, Plastic Surgery Class 1 878.4800 2008-11-07
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2008-11-07
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2007-12-14
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
GXJ Punch, Skull Neurology Class 1 882.4750 2008-03-14
HWJ Awl Orthopedic Class 1 888.4540 2008-11-07
HAE Rongeur, Manual Neurology Class 2 882.4840 2016-09-21
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-05-11
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2009-05-11
HTF Curette General, Plastic Surgery Class 1 878.4800 2008-11-07
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2011-06-18
HXE Fork Orthopedic Class 1 888.4540 2008-11-07
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2008-11-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-14
DZN Instruments, Dental Hand Dental Class 1 872.4565 2019-03-27
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2009-07-24
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2008-11-07
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 1998-02-04
HXG Tamp Orthopedic Class 1 888.4540 2008-11-07
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-11-07
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
EMI File, Bone, Surgical Dental Class 1 872.4565 2019-03-27
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2008-11-07
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2008-11-07
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2008-11-07
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 1998-02-04
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2014-11-10
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2008-11-07
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2008-11-07
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2008-11-07
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2011-06-18
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1993-03-19
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2008-11-07
HWW Countersink Orthopedic Class 1 888.4540 2010-08-18
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2014-11-10
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2008-11-07
JXT Crimper, Wire, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2008-11-07
HNK Probe, Trabeculotomy Ophthalmic Class 1 886.4350 2008-11-07
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 1998-02-04
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2008-11-07
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2014-11-10
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2008-11-07
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-11-07
HXB Probe Orthopedic Class 1 888.4540 2008-11-07
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2008-11-07
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2008-11-07
HTX Rongeur Orthopedic Class 1 888.4540 2002-07-01
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2019-03-27
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2010-03-08
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2014-11-10
HXX Screwdriver Orthopedic Class 1 888.4540 2010-08-18
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2008-11-07
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2008-11-07
HNY Cystotome Ophthalmic Class 1 886.4350 2008-11-07
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2008-11-07
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2008-11-07
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2014-11-10
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2014-11-10
HWB Extractor Orthopedic Class 1 888.4540 2008-11-07
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2005-03-01
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2009-05-11
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2008-11-07
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 1998-02-04
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2010-08-18
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2019-03-27
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2008-11-07
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2008-11-07
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2016-09-21
HGC Clamp, Uterine Obstetrics/Gynecology Class 1 884.4520 2014-11-10
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2008-11-07
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2008-11-07
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-11-07
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2007-12-14
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1998-02-04
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2009-07-24
HSO Saw General, Plastic Surgery Class 1 878.4800 2008-11-07
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2014-11-10
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2009-04-22
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2019-03-27
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2009-09-25
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-09-15
HWQ Passer Orthopedic Class 1 888.4540 2008-11-07
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2008-11-07
GAD Retractor General, Plastic Surgery Class 1 878.4800 2008-11-07
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2008-11-07
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 2008-11-07
EIG Retractor, All Types Dental Class 1 872.4565 2019-03-27
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-11-10
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2008-11-07
HWA Impactor Orthopedic Class 1 888.4540 2008-11-07

Official Correspondent

John Ryall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BOSS INSTRUMENTS, LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19
K933812 Advanced Surgical, Inc. ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES 1993-12-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1056350. Last updated year: 2026. Please use registration number 1056350 when referencing this establishment in official correspondence.
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