FDA.reportPublic FDA data

Histolock

Primary DI
10724995182622
Brand
Histolock
Company
STERIS CORPORATION
Model
00711117
Catalog number
00711117
Device description
The Histolock resection device is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.
Published
2020-03-19
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
FDISNARE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140763000MONOFILAMENT POLYPECTOMY SNAREUnited States Endoscopy2014-04-24FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995182622PackageGS110In Commercial Distribution
00816765012727PreviousGS10
00724995182625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518262210724995182622
00816765012727008167650127278167650127270816765012727
00724995182625007249951826257249951826250724995182625

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Outer Diameter2.4Millimeter
Width14Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
139424188
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995247317SmartBand EMR KitUS EndoscopyFDI2025-11-21
00724995247324SmartBand EMR PackUS EndoscopyFDI2025-11-21
00724995220051Roth NetUS EndoscopyFDI2024-11-25
00724995220068Roth Net PlatinumUS EndoscopyFDI2024-11-25
00724995194369CoinTipUS EndoscopyFDI2020-06-11
00724995194376CoinTipUS EndoscopyFDI2020-06-11
00724995194383CoinTipUS EndoscopyFDI2020-06-11
00724995182878HistolockUS EndoscopyFDI2020-04-02
00724995182908Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182915Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182922Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182939Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19
00724995182533Roth NetUS EndoscopyFDI2020-03-19
00724995182540Polyp PakUS EndoscopyFDI2020-03-19
00724995182571LariatUS EndoscopyFDI2020-03-19
00724995182588LariatUS EndoscopyFDI2020-03-19
00724995182595Short ThrowUS EndoscopyFDI2020-03-19
00724995182601TraxtionUS EndoscopyFDI2020-03-19
00724995182625HistolockUS EndoscopyFDI2020-03-19