FDA.reportPublic FDA data

Speedboat Notch Long

Primary DI
05060359561480
Brand
Speedboat Notch Long
Company
CREO MEDICAL LIMITED
Model
PRD-SB1-003
Catalog number
PRD-SB1-003
Device description
Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract. This is the eIFU configuration.
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060359561497PackageGS11In Commercial Distribution
05060359561503PackageGS11In Commercial Distribution
05060359561510PackageGS15In Commercial Distribution
05060359561480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060359561497050603595614975060359561497
05060359561503050603595615035060359561503
05060359561510050603595615105060359561510
05060359561480050603595614805060359561480

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical/microwave submucosal lift/resection instrumentA flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a lift solution delivery needle or lumen, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+18662261170uscustomerservice@creomedical.com
+441291637300customerservice@creomedical.com

Regulatory Flags#

DUNS number
733853373
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
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060359561404Speedboat Ultraslim LongPRD-SB1-001PRD-SB1-0012026-10-01
05060359561442Speedboat UltraSlim ShortPRD-SB1-002PRD-SB1-0022026-10-01
05060359561527Speedboat Notch ShortPRD-SB1-004PRD-SB1-0042026-10-01
05060359561565SpydrBlade FlexPRD-RG1-001PRD-RG1-0012026-10-01
05060359561602Footswitch7-PG1-1327-PG1-1322026-10-01
05060359561626Reusable Interface Cable, 1.5 mPRD-IFC-002PRD-IFC-0022026-10-01
05060359560100Footswitch7-PG1-1327-PG1-1322026-04-17
05060359560209MicroBlate Flex7-AB1-0012021-07-29
05060359560513Croma Generator7-EMR-050 V6.017-EMR-0502024-01-09
05060359560575Speedboat RS2 8 Fr Instrument7-RS2-0037-RS2-0032023-11-08
05060359560643Speedboat Ultraslim LongPRD-SB1-001PRD-SB1-0012023-12-06
05060359561183CROMA Electrosurgical Generator7-EMR-050 V6.0017-EMR-0502024-10-08
05060359560292CROMA Electrosurgical Generator7-EMR-050 V4.02021-03-15
05060359560223SlypSeal Flex7-HS1-0017-HS1-0012020-12-31
05060359560070Interface Cable, single use, 1.5 m2-RS2-2102-RS2-2102020-11-23
05060359560025Speedboat Inject 10 Fr7-RS2-0017-RS2-0012018-11-14
05060359560063Procedure Pack Interface Cable, single use, 1.5 m7-RS2-210 7-RS2-2102018-11-15
05060359560087CROMA Electrosurgical Generator with Footswitch7-EMR-050 2018-11-15
05060359560124CROMA Electrosurgical Generator7-EMR-050 V3.07-EMR-0502019-03-20
05060359560674Speedboat UltraSlim ShortPRD-SB1-002PRD-SB1-0022025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060359561404Speedboat Ultraslim LongCREO MEDICAL LIMITEDKNS2026-10-01
05060359561442Speedboat UltraSlim ShortCREO MEDICAL LIMITEDKNS2026-10-01
05060359561527Speedboat Notch ShortCREO MEDICAL LIMITEDKNS2026-10-01
05060359561565SpydrBlade FlexCREO MEDICAL LIMITEDKNS2026-10-01
05060359561602FootswitchCREO MEDICAL LIMITEDKNS2026-10-01
05060359561626Reusable Interface Cable, 1.5 mCREO MEDICAL LIMITEDKNS2026-10-01
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901663NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901687NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901700NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901717NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664903520NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910566NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910597NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911976NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912096NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912102NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17