Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2182291

FEI Number

2182291

Entity Name

VESTA

City/State/Country

Franklin, WI, US

Establishment Address

9900 S 57th St, Franklin, WI 53132, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Vesta (Owner Number: 10043140)

Owner / Operator Contact Address

9900 S 57th St, Franklin, WI 53132, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Boston Scientific - 32 Contact Long Paddle Blank (VPN 26210) Boston Scientific - 32 Contact Short Paddle Blank (VPN 26209) Gastrointestinal Boundary Identifier (GIBI HD) Subtle® Cannula with Guide, 30cm Subtle® Cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2023-03-27
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2023-03-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-08-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-06-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-03-23
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2022-02-10
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2015-03-23
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-01-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-01-28
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2021-05-05

Official Correspondent

Christopher Kobus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vesta

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Similar Registrations

Registration Number	Establishment Name	Location
3016618265	Cirtec Medical	Coyol Alajuela, CR
3020969413	Nevro Medical S.R.L.	El Coyol Alajuela, CR
3008514029	NEVRO CORP.	Redwood City, CA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
2182207	MEDTRONIC NEUROMODULATION	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2182291. Last updated year: 2026. Please use registration number 2182291 when referencing this establishment in official correspondence.