GRACE MANUFACTURING INC

FDA Device Registration & Listing · Russellville, AR, US · Registration 1651252

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
1651252
FEI Number
3002770040
Entity Name
GRACE MANUFACTURING INC
City/State/Country
Russellville, AR, US
Establishment Address
614 SR 247, Russellville, AR 72802, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Grace Manufacturing Inc (Owner Number: 10042478)
Owner / Operator Contact Address
614 SR 247, Russellville, AR 72802, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Reusable Monopolar Active Cord Active Cord BSC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2015-12-17
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2015-12-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-03-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-12-17
FBJ Cord, Electric For Transurethral Surgical Instrument Gastroenterology, Urology Class 2 876.4300 2015-12-17
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2015-12-18
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2015-12-17
HTO Reamer Orthopedic Class 1 888.4540 2012-11-30
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 2015-12-17
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2015-12-17
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2015-12-17
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2015-12-17
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2015-12-17
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2015-12-17
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-12-06

Official Correspondent

Shanyce Day

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Grace 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-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
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1651252. Last updated year: 2026. Please use registration number 1651252 when referencing this establishment in official correspondence.
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