FDA.reportPublic FDA data

Sterion® Cautery Tip Cleaner

Primary DI
00887761000322
Brand
Sterion® Cautery Tip Cleaner
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
032001BBG
Device description
Provides a method of removing eschar build-up from the tip of an electrosurgical instrument during a procedure.
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030339000CAUTERY TIP CLEANER, MODEL-TC-100Aspen Surgical Products, Inc.2003-03-07GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761000322PrimaryGS10
00887761005556Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761000322008877610003228877610003220887761000322
00887761005556008877610055568877610055560887761005556

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical tip cleaning padA sterile wad used to periodically wipe clean (i.e., remove eschar build-up) a tip (e.g., an electrode or blade) used in an electrically-mediated surgical technique for cutting, coagulating, or cauterizing tissue. The device is typically abrasive on one side to facilitate cleaning, and adhesive on the other side so that it may be conveniently affixed to an easy access object in the operative arena (e.g., surgical drape, mayo stand). It may include a radiopaque thread making it visible on x-ray. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
50
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04
00840113233465BovieH1112026-09-04
00840113233489BovieH1122026-09-04
00840113233502BovieH1212026-09-04
00840113233526BovieHISL2026-09-04
00840113237326BovieESP1N2026-09-04
00840113237340BovieESP1H2026-09-04
00840113237593BovieESP7N2026-09-04
00840113237623BovieESP7H2026-09-04
00840113237661BovieESP6N2026-09-04
00840113237692BovieESP6H2026-09-04
00840113242573BovieST052026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26