Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183650

FEI Number

2183650

Entity Name

SHONEY SCIENTIFIC, INC.

City/State/Country

WAUKESHA, WI, US

Establishment Address

WEST 223 NORTH 720 SARATOGA, DR., SUITE 120, WAUKESHA, WI 53186, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SHONEY SCIENTIFIC, INC. (Owner Number: 2183650)

Owner / Operator Contact Address

WEST 223 NORTH 720 SARATOGA, DR., SUITE 120, Waukesha, WI 53186, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

McKesson Punch Ear Well IV Set STETHOSCOPE-MONOSCOPE Luer to Luer Connector Others nonproprietary IUD Remover 1Scope-HD Blade (Disposable) IUD Insertion Kit BPS Wrist Fracture Implants Dennis Dilator - Gynex Tru-Punch - Sklar Gynex Keye's Punch Brecise Inno Infiltration Tubing Disposable Osseous Bone Trap No proprietary names Suresample AIROS 6P Cache Nipple Shields NA AIROS 8P #1 Urinal Reinjection Tubing PhemAlert - Gynex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2006-03-20
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2010-11-16
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1996-10-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-01-13
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2007-01-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-08-12
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2017-09-15
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2024-06-03
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-09-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-02-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-19
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2002-06-05
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	1996-10-25
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2007-10-29
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-11-16
MXP	Bone Particle Collector	Ear, Nose, Throat	Class 1	874.4800	2010-09-27
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-09-24
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2012-05-22
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2010-09-27
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-11-03
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-08-08
NOK	Material, External Aesthetic Restoration, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2008-07-03
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-07-21
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2011-11-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-08-08
FNP	Urinal	General Hospital	Class 1	880.6730	2022-01-26
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2024-06-03
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2005-08-04
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2024-02-09
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2015-07-13

Official Correspondent

SANJAY SHONEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SHONEY SCIENTIFIC, 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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2011	Medical Device Technologies, Inc.	1	Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1 Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS Model Number: 763116200X Lot #'s 121KN Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW. Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. Model Number: 763418250X Lot #s 92751X60, 00671ZRL, Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183650. Last updated year: 2026. Please use registration number 2183650 when referencing this establishment in official correspondence.