Custom Manufacturing Inc.

FDA Device Registration & Listing · Elbert, CO, US · Registration 1721251

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1721251
FEI Number
1721251
Entity Name
Custom Manufacturing Inc.
City/State/Country
Elbert, CO, US
Establishment Address
12001 County Road 94, Elbert, CO 80106, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Custom Manufacturing, Inc. (Owner Number: 1721251)
Owner / Operator Contact Address
12001 County Rd. 94, --, Elbert, CO 80106, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Covidien - Valleylab E0600 REM Patient Return Electrode Adapter Covidien - Valleylab Straight E1502 and E1504 Electrode Extensions Viant Medical - 02191 and 02867 Phrenic Nerve Pad Covidien E1502 & E1504 Electrode Extensions Covidien - Valleylab E0600 REM Patient Return Electrode Adapter Covidien - Valleylab Straight E1502 and E1504 Electrode Extensions Covidien - Valleylab E0600 REM Patient Return Electrode Adapter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1992-05-07
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2024-05-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-22

Official Correspondent

Jessica Mead

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Custom Manufacturing, 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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0037-05 N/A 2
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721251. Last updated year: 2026. Please use registration number 1721251 when referencing this establishment in official correspondence.
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