Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005575604

FEI Number

3005575604

Entity Name

SURETEK MEDICAL

City/State/Country

GREENVILLE, SC, US

Establishment Address

25-B MAPLE CREEK CIRCLE, GREENVILLE, SC 29607, US

Establishment Type(s)

Reprocess Single-Use Device

Owner / Operator

SURETEK MEDICAL (Owner Number: 9082027)

Owner / Operator Contact Address

25-B MAPLE CREEK CIRCLE, --, Greenville, SC 29607, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reprocessed Orthopedic Saw Blades Reprocessed Surgical Bur Reprocessed Manual ENT Instrument Reprocessed Inflation Syringe Reprocessed Sinus Cannula Reprocessed Sinuplasty Balloon Catheter Reprocessed Orthopedic Bone Tap Reprocessed Surgical Reamer Reprocessed Suture Grasper, Lasso, Retriever Reprocessed Sinus Cannula Reprocessed ENT Shavers Reprocessed Arthroscopic Shavers and Burs Reprocessed Passer Reprocessed Orthopedic Burs and Saw Blades Reprocessed ENT Blades and Burs SURETEK REPROCESSED ELE Reprocessed Monopolar and Bipolar Electrosurgical Cutting and Coagulation Devices Reprocessed Surgical Rasp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2006-01-20
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2006-01-20
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-11-23
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2006-01-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2006-01-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2006-01-20
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2013-12-15
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2006-02-16
HWQ	Passer	Orthopedic	Class 1	888.4540	2013-12-15
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2006-02-16
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2008-04-20
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2006-06-16
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2006-01-20

Official Correspondent

MIKE SAMMON, PH.D.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURETEK MEDICAL

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
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005575604. Last updated year: 2026. Please use registration number 3005575604 when referencing this establishment in official correspondence.