Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015177815

FEI Number

3015177815

Entity Name

Hubot, Inc.

City/State/Country

South Bend, IN, US

Establishment Address

3333 N. Kenmore St, South Bend, IN 46628, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hubot, Inc. (Owner Number: 10058602)

Owner / Operator Contact Address

3333 N. Kenmore St, South Bend, IN 46628, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2021-10-12
MLY	Vapocoolant Device	Unknown	Class U	N/A	2025-08-27
MLY	Vapocoolant Device	Unknown	Class U	N/A	2025-08-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-08-27
MLY	Vapocoolant Device	Unknown	Class U	N/A	2021-10-12

Official Correspondent

Paras Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hubot, 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
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

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3012697079	COOL RENEWAL, LLC	Nashville, TN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015177815. Last updated year: 2026. Please use registration number 3015177815 when referencing this establishment in official correspondence.