Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2433012

FEI Number

2433012

Entity Name

BUSSE HOSPITAL DISPOSABLES

City/State/Country

HAUPPAUGE, NY, US

Establishment Address

75 ARKAY DR., HAUPPAUGE, NY 11788, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

ROBERT BUSSE & CO., INC. (Owner Number: 2417536)

Owner / Operator Contact Address

75 ARKAY DR., --, HAUPPAUGE, NY 11788, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Quincke Style Spinal Needle 22g x 3 1/2" Quincke Style Long Legth Spinal Needle 22g x 5" Quincke Style Spinal Needle 25g x 3 1/2" Tuohy Epidural Needle 18g x 3 1/2" without wings Sterile Whitcare Style Spinal Needle 25g x 3 1/2" Quincke Style Spinal Needle 22g x 1 1/2" Tuohy Epidural Needle 18g x 3 1/2" with removable wings Quincke Style Spinal Needle 20g x 3 1/2" Tuohy Epidural Needle 18 x 3 1/2" with fixed wings Quincke Style Spinal Needle 18g x 3 1/2" Tuohy Epidural Needle 18g x 3 1/2" with wings Quincke Style Long Length Spinal Needle 22g x 7" Tuohy Epidural Needle 20g x 3 1/2" without wings Tuohy Epidural Needle 20g x 3 1/2" with fixed wings PLASTIC APRON 7mm Straight Curette 7mm Curved Curette 11mm Straight Curette 8mm Straight Curette 8mm Curved Curette 14mm Straight Curette 9mm Curved Curette 9mm Straight Curette 12mm Curved Curette 11mm Curved Curette 10mm Straight Curette 12mm Straight Curette 14mm Curved Curette 10mm Curved Curette J-Style Bone Marrow / Aspiration Needle - 630 I.V. Start Kit with Sepp & Tegaderm Dressing I.V. Start Kit with Tegaderm Dressing I.V. Start Kit Tracheostomy Dressing Peripheral Catheter Insertion Kit Accessories Arthrogram Tray - 957 Safety-Deluxe Arthrogram Tray - 979 Busse Paracentesis Tray Sterile Circumcision Tray EpiGlide loss of Resistance (LOR) Syringe - 10ml Plastic Loss of Resistance (LOR) Syringe with Luer Slip Tip - 596 10ml LOR Luer Lock Syringe - 5950 EpiGlide Loss of Resistance (LOR) Syringe - 10ml Plastic Loss of Resistance (LOR) Syringe with Luer Lock Tip - 595 10ml LOR Luer Slip Syringe - 5960 Pellet Insertion Tray Straight Kelly Hemostat Curved Kelly Hemostat Angled Sponge Stick - 6474 Surgical Instruments Obstetrical Kit, Box Obstetrical Kit, Pouch Absorbent Towels XXXX Large white - SMS Tri-layered Lab Coat with knit cuffs - 236 Coveralls, Extra Large, white, zipper front - 213 Fluid Resistant Gown - White, full Back Polycoated - 200 Lab Coats, Large/Extra Large, White - SMS - Tri-layered with knit cuffs - 225 Isolation Gown, Yellow - 202 Deluxe Staff Protection Kit - 198 Suture Removal Kit with Stitch Cutter Suture Removal Kit Classic Sutture Removal Tray Basic Suture Removal Kit with Floor Grade Instruments Amniocentesis Tray with 20g x 3.5 Spinal Needle Amniocentesis Tray with 20g x 3.5 Spinal Needle (includes Safety Components) Safety Deluxe Amniocentesis Tray BUSSE HOSPITAL DISPOSA Amniocentesis Tray with 20g x 3.5" Spinal Needle - 650B Busse Hysteroscopy Pack / Tray GLASS LOSS OF RESISTANCE SYRINGE BUSSE LOSS OF RESISTANCE SYRINGE Sterile Skin Staple Remover - 770 Sterile Skin Staple Remover - Stainless Steel with Plastic handles - 772 Sterile Skin Staple Remover - 716 3/8" "Y" Conncetor 6-In-1 "Y" Connector Catheter Plug with Drainage Tube Cover 6mm Straight Connector "T" Connector Sims Connector 10mm Straight Connector 8mm Straight Connector Busse Extension Sets Myelogram Tray Safety Deluxe Myelogram Tray Pump Refill Kit Nerve Block Tray Single Shot Epidural Tray with 18g x 3 1/2" - 679 Single Shot Epidural Tray - 670 Single Shot Epidural Tray with 20G x 3 1/2" - 677 Umbilical Cord Clamp I-Style Bone Marrow Aspiration Needle With T-Handle Extension Sets BUSSE HOSPITAL DISPOSABLES ICE BAG Personal Protection Gown 3 oz Bulb Syringe 1 oz Bulb Syringe 2 oz Bulb Syringe 3 oz Re-Usable Bulb Syringe 2 oz Re-Usable Bulb Syringe SAF-SHIELD Minor Procedure Pack General Purpose Instrument Tray Sterile Debridement Tray Suturing Tray Minor Laceration Tray with Instruments Facial wound Tray E.R. Laceration Tray with Safety Components Minor Laceration Tray Incision & Drainage Tray Incision & Drainage Tray with Safety Components INSTRUMENT TRAYS STERILE AND NON-STERILE Pediatric/Infant Puncture Tray with Spinal needle without manometer Pediatric/Infant Lumbar Puncture Tray with Spinal Needle and Manometer Lumbar Puncture Tray with 22g x 3 1/2" Spinal Needle and Manometer. Safety Deluxe Lumbar Puncture Tray Safety Deluxe Pediatric / Infant Lumbar Puncture Tray Busse Spinal Fluid Manometer Safety Deluxe Lumbar Puncture Tray with 22g x 3.5" Spinal Needle and Manometer - 975B Safety Pediatric/Infant Lumbar Puncture Tray with Spinal Needle and Manometer - 946B Safety Deluxe Lumbar Puncture Tray with 20g x 3.5" Spinal Needle and Manometer - 974B 6' x 1/2" Uterine Aspirating Tubing with Handle without Adaptor 6' x 3/16" ID Suction Tubing 6' x 1/4" ID Suction Tubing 6' x 1/2" Uterine Aspirating Tubing with Handle and adaptor 10' x 1/4" ID Suction Tubing 6' x 3/8" ID Uterine Aspirating Tubing with Handle and Adaptor I-Style Bone Marrow Aspiration Needle - 631 Fluid Injection Tray KITS STERILE MEDICATION LABELS BUSSE HOSPITAL DISPOSA Bone Marrow Biopsy / Aspiration Tray - 653B Bone Marrow Aspiration Tray - 655B Bone Marrow Biopsy / Aspiration Tray - 654 Bone Marrow Biopsy / Aspiration Tray - 653 Bone Marrow Aspiration Tray - 655 Safety Deluxe Bone Marrow Biopsy / Aspiration Tray - 985 Safety Deluxe Bone Marrow Biopsy Tray / Aspiration Tray - 988 Bone Marrow Biopsy / Aspiration Tray - 654B Bone Marrow Biopsy / Aspiration Tray - 652 Busse Carpal Tunnel Pack Umbilical Cord Clamp Bulk Packed Umbilical Cord Clamp SAF-T CUBE ALL PURPOSE BULB SYRINGE Frazier Suction Instrument Poole Suction Instrument Sigmoidoscope Suction Instrument Yankauer Suction Instrument 24" x 18" Blue Drape with 4" Fenestration with Adhesive Patch and Adhesive Strip 18" x 26" Blue / White Drape with Patch - Bulk 24" x 36" Blue / White Drape - Bulk 18" x 26" Blue / White Drape with 3" Fenestration - Bulk 18" x 26" Drape with 1.5" Fenestration - Bulk 24" x 30" Blue 4" Fenestration and Tape Strip 18" x 26" White Towel - Bulk 18" x 26" White Towel with Patch - Bulk 18" x 26" White Fenestrated Towel 16" x 16" white Drape - Bulk 21" x 36" Clear Drape - Non-sterile 15.5" x 25" Blue Drape with 3/4" Adhesive Strip 26" x 22" Blue SMS Drape with 4 x 4 square Fenestration and Adhesive 26" x 21" Blue SMS Drape with 2" x 3" Oval Fenestration - Bulk non-sterile 18" x 26" White / BPP / White Drape with 3" Fenestration 26" x 21" Blue SMS Drape - Bulk 15.5" x 25" Blue Drape w/adhesive near folded edge - non-Sterile 15.5" x 26" Blue Utility Drape - Bulk 15.5" x 25" Non-Absorbent Utility Drape - Non-Sterile 15.5" x 25" Blue SMS Non-Absorbent Fenestrated Drape - Bulk 26" x 21" Blue SMS Drape With 2" x 3" Oval Fenestration and Adhesive Patch - Bulk Pain Management Drape with Fenestration & Adhesive Strip - 24" x 30" Clear drape - 690 24" X 30" Clear Drape with 4" x 8" Rectangular Fenestration and Adhesive strip 24" x 30" Clear Drape with 4" Fenestration, Adhesive Patch & Adhesive Tabs 30" x 24" Clear Drape with 4" Round Fenestration and Adhesive Strip Sterile Titan(TM) Quincke Style Spinal Needle 22G x 3 1/2" - 562 Sterile Titan(TM) Quincke Style Spinal Needle 20G x 3 1/2" - 561 Sterile Titan(TM) Quincke Style Spinal Needle 18G x 3 1 1/2" - 560 Sterile Titan(TM) Quincke Style Spinal Needle 22G x 1 1/2" - 564 Sterile Titan(TM) Quincke Style Long Length Spinal Needle 22G x 7" - 566 Sterile Titan(TM) Quincke Style Long Length Spinal Needle 22G x 5" - 565 Sterile Titan(TM) Quincke Style Spinal Needle 25G x 3 1/2" - 563 Procedural Mask Fluid Resistant Mask with Face Shields Fluid Resistant Mask Busse Thoracentesis Tray Nurses' Scissors Littauer Scissors with Plastic Handle SCISSORS DISPOSABLE I.V. Start Kit w/Tegaderm Dressing I.V. Start Kit IV Start Kit w/ Sepp & Tegaderm Dressing Newborn Tape Measure Pediatric Tape Measure Measuring Devices Various Calculi Strainer Busse Eye Procedure Tray GLASS LOSS OF RESISTANCE SYRINGE Basic Soft Tissue Biopsy Tray without Biopsy Needle BUSSE HOSPITAL DISPOSA Calculi Strainer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2022-05-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-01-10
IWO	Apron, Protective	Radiology	Class 1	892.6500	1977-12-20
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1977-12-20
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2017-11-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-09-01
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2011-11-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-03-02
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2014-07-07
OII	Arthrogram Tray	Radiology	Class 2	892.1650	2013-03-28
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2009-10-15
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2013-03-28
OHG	Circumcision Tray	Obstetrics/Gynecology	Class 2	884.4530	2016-08-09
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2019-08-21
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1978-01-20
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2003-07-24
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	1995-12-20
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2011-09-22
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2004-09-08
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2012-03-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2004-11-05
HBS	Instrument, Clip Forming/Cutting	Neurology	Class 1	882.4190	1996-11-08
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2003-07-24
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2015-02-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-02-26
OGJ	Nerve Block Tray	Anesthesiology	Class 2	868.5140	2020-03-06
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2011-12-09
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2026-01-07
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-09-13
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2012-07-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-07-19
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2004-09-08
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2025-03-26
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-04-01
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-01-16
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1994-07-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-03-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-03-08
FMJ	Manometer, Spinal-Fluid	General Hospital	Class 2	880.2500	2009-06-04
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	1978-01-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-08
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-09-11
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2019-07-23
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-03-26
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2013-03-28
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-03-28
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2006-03-10
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2004-11-05
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2019-04-05
PRV	Gastro-Urology Biopsy Kit	Gastroenterology, Urology	Class 2	876.1075	2020-11-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-04-01
OJG	Neurological Tray	Neurology	Class 1	882.4525	2019-08-01
DRC	Trocar	Cardiovascular	Class 2	870.1390	2016-08-05
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2017-07-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-01-10
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	1996-11-08
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-09-15
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2011-05-03
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2013-06-13
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-07-26
OIM	Mri Disposable Kit	Radiology	Class 2	892.1000	2016-08-10
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2025-12-22
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-10-26
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-08-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-12-03
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2009-06-04
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1996-10-30
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2018-05-24
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2011-11-28
JNQ	Qualitative Chemical Reactions, Urinary Calculi (Stone)	Clinical Chemistry	Class 1	862.1780	2004-09-08
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2013-03-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2004-11-05
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2004-09-08
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2016-08-10
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2013-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ROBERT BUSSE & CO., 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
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2009	Medline Industries Inc	2	Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0016-2009	Medline Industries Inc	2	Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0017-2009	Medline Industries Inc	2	Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0018-2009	Medline Industries Inc	2	Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0019-2009	Medline Industries Inc	2	Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2433012. Last updated year: 2026. Please use registration number 2433012 when referencing this establishment in official correspondence.