FDA.reportPublic FDA data

Mammotome Revolve EX

Primary DI
10841911102349
Brand
Mammotome Revolve EX
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
MHEX08S
Catalog number
CA000460001
Device description
Revolve EX Ultrasound Probe with Sleeve - System Registered- CE
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202012000Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemDevicor Medical Products, Inc.2020-08-18KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841911102349PackageGS15In Commercial Distribution
00841911102342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191110234910841911102349
00841911102342008419111023428419111023420841911102342

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961832156
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
00841911103776Mammotome PrimaMRPROBE08CA0007780012026-06-09
00841911102434Mammotome HydroMARK4010-05-10-T3CA0005200022022-03-02
00841911103677Hydromark4010-05-10-T3CA0005200052024-08-29
00841911101239MammotomeVAS08VAS082022-02-04
00841911101246MammotomeVAS11VAS112022-02-04
00841911103158Mammotome Revolve EXMCART1CA0008990012025-09-16
00841911101819MammotomeSCMC1DIRECT MARK GTIN2022-02-09
00841911101826MammotomeSCMC3DIRECT MARK GTIN2022-02-09
00841911101765MammotomeMFSW1DIRECT MARK2022-02-08
00841911101864Mammotome revolveMFOOT1DIRECT MARK2022-02-08
00841911101871Mammotome revolveMHKEYP1DIRECT MARK2022-02-08
00841911101888MammotomeMRLB1DIRECT MARK GTIN2022-02-08
00841911100539Mammotome MammoTestB1021B10212016-11-10
00841911100553MammotomeMFSW1MFSW12016-11-10
00841911100560MammotomeMKEY1MKEY12016-12-13
00841911100584MammotomeMRLB1MRLB12016-12-13
00841911100614MammotomeSCMC1SCMC12016-11-10
00841911100621MammotomeSCMC3SCMC32016-11-10
00841911100652Mammotome revolveMCART1MCART12016-11-10
00841911100669Mammotome revolveMFOOT1MFOOT12016-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103776Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-06-09
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31