Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004571672

FEI Number

3004571672

Entity Name

Fischer Surgical Inc.

City/State/Country

Imperial, MO, US

Establishment Address

1012 Palmer Ln Suite 200, Imperial, MO 63052, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FISCHER SURGICAL INC. (Owner Number: 9063538)

Owner / Operator Contact Address

1012 Palmer Lane, Suite 200, Imperial, MO 63052, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clamp, muscle, ophthalmic SCISSORS, OPHTHALMIC TRAY, SURGICAL, INSTRUMENT Marker, ocular FORCEPS CUTTER, WIRE BLADE, SCALPEL Graft insertion instrument for endothelial keratoplasty Curette, ophthalmic CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY Caliper, ophthalmic Depressor, orbital Gauge, lens, ophthalmic Retractor, ophthalmic Cannula, ophthalmic, posterior capsular polishing, polyvinyl acetal JOINT, ANKLE, EXTERNAL BRACE RETRACTOR, VAGINAL SNARE, TONSIL Spoon, ophthalmic RING, OPHTHALMIC (FLIERINGA) FORCEPS, ENT Gauge, lens, ophthalmic CLAMP SCISSORS, NASAL Probe, lachrymal PROBE, ENT Hook, ophthalmic PUNCH, ENT Instrument, measuring, corneal radius CURETTE, EAR INSTRUMENT, MANUAL, SURGICAL, GENERAL USE SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY TUBE, EAR SUCTION ELEVATOR INSTRUMENT, SURGICAL, NON-POWERED SAW Punch, corneo-scleral CUTTER, SURGICAL DISK, ABRASIVE SPECULUM, ENT RONGEUR PROBE MALLET, SURGICAL, GENERAL & PLASTIC SURGERY CHISEL (OSTEOTOME) SCISSORS, EAR DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY TAPE, MEASURING, RULERS AND CALIPERS KNIFE, ENT LARYNGOSCOPE, RIGID Spud, ophthalmic HOOK, SURGICAL, GENERAL & PLASTIC SURGERY DILATOR, CERVICAL, FIXED SIZE SPECULUM, NON-ILLUMINATED RETRACTOR Rongeur, lachrymal sac Needle, ophthalmic suturing INSTRUMENT, MICROSURGICAL SPECULUM, VAGINAL, METAL MARKER, SKIN MIRROR, ENT SCISSORS, GENERAL, SURGICAL CURETTE, ADENOID HANDLE, SCALPEL PICK, MICROSURGICAL EAR Trephine, manual, ophthalmic OSTEOTOME RASP, NASAL BLOCK, CUTTING, ENT, NON-STERILE GAG, MOUTH Knife, ophthalmic TAMP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-02-07
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-05-17
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2009-11-02
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2019-02-07
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2019-02-07
OTZ	Graft Insertion Instrument For Endothelial Keratoplasty	Ophthalmic	Class 1	886.4300	2012-12-29
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-11-02
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-11-02
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2019-02-07
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2009-11-02
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-11-02
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2009-11-02
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-02-07
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2019-02-07
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-11-02
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2019-02-07
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2009-11-02
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2019-02-07
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2004-05-17
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-05-17
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HJB	Instrument, Measuring, Corneal Radius	Ophthalmic	Class 1	886.1450	2019-02-07
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-02-07
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-02-07
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2004-05-17
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2019-02-07
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-02-07
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2019-02-07
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2019-02-07
HTX	Rongeur	Orthopedic	Class 1	888.4540	2019-02-07
HXB	Probe	Orthopedic	Class 1	888.4540	2019-02-07
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-02-07
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2019-02-07
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-02-07
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2019-02-07
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2019-02-07
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-05-17
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2019-02-07
FXE	Speculum, Non-Illuminated	General, Plastic Surgery	Class 1	878.1800	2019-02-07
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-02-07
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2019-02-07
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2004-05-17
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2004-05-17
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2019-02-07
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2019-02-07
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-02-07
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2019-02-07
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-02-07
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2019-02-07
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2019-02-07
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2019-02-07
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-11-02
HXG	Tamp	Orthopedic	Class 1	888.4540	2019-02-07

Official Correspondent

CRAIG FISCHER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FISCHER SURGICAL INC.

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
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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

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3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN
3017857440	HASA OPTIX	Brussels Brussels-Capital Region, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004571672. Last updated year: 2026. Please use registration number 3004571672 when referencing this establishment in official correspondence.