Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183785

FEI Number

2183785

Entity Name

Key Surgical, LLC

City/State/Country

Eden Prairie, MN, US

Establishment Address

8101 Wallace Road, Eden Prairie, MN 55344, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

STERIS Corporation (Owner Number: 10023158)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Solution Bucket/Pail Kick Bucket Endoscope Brush Pipe Cleaners Polypropylene Brushes Scope Cleaning Brushes Sterilization Wrap Skin Marker Sterilization Wrap Sterile Labels BOWLS BASINS and PITCHERS MEDICINE CUP Tumbler Cautery Tip Cleaner Suture Booties, Silicone Clamp Covers Mr. Clear Electro Lube K-Wire and Steinmann Pin Endoscopic Bite Block Needle Counter Plastic Instruments Towel & Utility Clamp (KS385) Bone Reamer Brush Acetabular Brush K-Wire & Steinmann Pin Rack Sponge Bowl Instrument Trays Wash Basins K-Wire and Pin Cover Micro Mesh Trays Plastic Sterilization Trays Mesh Trays Corner Protector (KS-SD,RR) Hand Immobilizer Drill Bits Funnel Storage Container Beaker Dressing Jar Utility Scoop Measuring Pitcher Forceps Jar Ointment Jar Emesis Basin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKW	Utensil, Homemaking	Physical Medicine	Class 1	890.5050	2023-07-29
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-12-21
FNP	Urinal	General Hospital	Class 1	880.6730	2023-07-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-02-02
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2015-04-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-06-24
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-02-02
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2016-01-18
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2023-07-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-05-22
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-06
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2019-05-07
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2015-03-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-05-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-05
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-11-05
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2018-07-13
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-09-25
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2017-04-03
HTO	Reamer	Orthopedic	Class 1	888.4540	2021-03-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-03-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-06
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-03-03
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-07-13
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2019-05-07
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2023-07-29
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-07-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

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-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183785. Last updated year: 2026. Please use registration number 2183785 when referencing this establishment in official correspondence.