FDA.reportPublic FDA data

Leapmed

Primary DI
06941165038634
Brand
Leapmed
Company
Suzhou Leapmed Healthcare Corporation
Model
11100506
Catalog number
11100506
Device description
Disposable Semi Automatic Biopsy Instrument, Model: A, 18G×20cm
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K212820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212820000Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation2022-07-06KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941165038634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941165038634069411650386346941165038634

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Needle Gauge18Gauge

Regulatory Flags#

DUNS number
544411637
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941165038870Leapmed11200106112001062026-04-01
06941165038887Leapmed11200206112002062026-04-01
06941165038894Leapmed11200306112003062026-04-01
06941165038900Leapmed11200406112004062026-04-01
06941165038917Leapmed11200506112005062026-04-01
06941165038924Leapmed11200606112006062026-04-01
06941165040118Leapmed11200706112007062026-04-01
06941165059790Leapmed28-FN15G728-FN15G72026-04-01
06941165059806Leapmed28-CN15G728-CN15G72026-04-01
06941165063575Leapmed28-CN17GT28-CN17GT2026-04-01
06941165063599Leapmed28-CN17G728-CN17G72026-04-01
00848340020629Leapmed28-CO182028-CO18202026-03-31
06941165038597Leapmed11100106111001062026-03-31
06941165038603Leapmed11100206111002062026-03-31
06941165038610Leapmed11100306111003062026-03-31
06941165038627Leapmed11100406111004062026-03-31
06941165038641Leapmed11100606111006062026-03-31
06941165038658Leapmed11100706111007062026-03-31
06941165038665Leapmed11100806111008062026-03-31
06941165038672Leapmed11100906111009062026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937278630643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630841CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630858CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630865CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630872CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630889CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630896CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630902CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630919CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630926CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631046CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631053CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631060CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631077CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631084CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631091CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631107CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631114CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631138CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631145CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08