FDA.reportPublic FDA data

SureTome SW

Primary DI
10827002613529
Brand
SureTome SW
Company
COOK INCORPORATED
Model
G61352
Catalog number
SUR-SW-AWG2-35-450
Device description
SureTome SW Sphincterotome with DomeTip
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251104000SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical2025-09-29KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002613529PackageGS11In Commercial Distribution
00827002613522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700261352910827002613529
00827002613522008270026135228270026135220827002613522

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
079720472
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002007475CookG00747T9.0-65-45-M-NS-TJC2016-09-24
00827002071261CookG07126T9.0-65-45-NM-NS-TJC2016-09-24
00827002342538AprimaG34253NSSW-4.0-18-NPAS-100-HC-SST2020-10-15
00827002067622CookG06762PLVW-5.5-25-PICS2020-10-02
00827002116306ChaitG11630CTU10.0-18-CAA2020-10-02
00827002577862Check-Flo PerformerG57786RCF-4.0-21-7-J-012020-07-07
00827002577879Check-Flo PerformerG57787RCF-4.0-35-J-012020-07-07
00827002577886Check-Flo PerformerG57788RCF-5.0-35-J-012020-07-07
00827002577893Check-Flo PerformerG57789RCF-5.0-38-J-012020-07-07
00827002577909Check-Flo PerformerG57790RCF-6.0-35-J-012020-07-07
00827002577916Check-Flo PerformerG57791RCF-6.0-38-J-012020-07-07
00827002577923Check-Flo PerformerG57792RCF-7.0-35-J-012020-07-07
00827002577930Check-Flo PerformerG57793RCF-7.0-38-J-012020-07-07
00827002577947Check-Flo PerformerG57794RCF-8.0-38-J-012020-07-07
00827002577954Check-Flo PerformerG57795RCFP-5.5-25-J-012020-07-07
00827002577961Check-Flo PerformerG57796RCFW-5.0-35-012020-07-07
00827002275010TurcotteG27501HDC-500-TURCOTTE-0429922016-09-24
00827002275027TurcotteG27502HDC-600-TURCOTTE-0429922016-09-24
00827002313941VertefixG31394VBC-1002016-04-28
00827002363922ChaitG36392TDCS-100-M2016-09-24

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