Resitu Slider 09

Primary DI
17350142820036
Brand
Resitu Slider 09
Company
Resitu Medical AB
Model
RESL09
Device description
Resitu Slider 09 (RESL09) is a minimally invasive, vacuum assisted device, intended to provide large intact breast tissue samples for histologic examination of imaged abnormalities. The device is provided sterile and is for single-use. Resitu Slider 09 is hand-held (vacuum is created in the handle) and is part of a monopolar high frequency electrosurgical system.
Published
2026-11-05
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

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
K252183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252183000Resitu Slider 09 (RESL09)Resitu Medical AB2025-09-24KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350142820036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1735014282003617350142820036

Regulatory Flags#

DUNS number
350736519
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936666568834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664563CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664570CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664587CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664594CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664600CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664617CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664624CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664631CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664648CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664655CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664662CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664679CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664686CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664693CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664709CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664716CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664723CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664730CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664747CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664754CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664761CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664778CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664785CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664792CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664808CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664815CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664822CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664839CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664846CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05