FDA.reportPublic FDA data

MicroBlate Fine

Primary DI
05060359560490
Brand
MicroBlate Fine
Company
CREO MEDICAL LIMITED
Model
7-NP1-100
Catalog number
7-NP1-100
Device description
MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
Published
2025-05-05
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
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221672000Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.2023-02-14NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060359560483PackageGS15In Commercial Distribution
05060359560490PackageGS11In Commercial Distribution
05060359560971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060359560483050603595604835060359560483
05060359560490050603595604905060359560490
05060359560971050603595609715060359560971

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system probe, non-poweredA non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.9Meter
Outer Diameter2.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure69 KiloPascal109 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18662261170uscustomerservice@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
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
05060359561329Speedboat Notch ShortPRD-SB1-004PRD-SB1-0042025-10-03
05060359560438SpydrBlade FlexPRD-RG1-001PRD-RG1-0012025-06-12
05060359560971MicroBlate Fine7-NP1-1007-NP1-1002025-05-05
05060359561077Speedboat Notch LongPRD-SB1-003PRD-SB1-0032025-03-26
05060359561206CROMA Electrosurgical GeneratorPRD-EMR-050PRD-EMR-0502025-02-10
05060359561213CROMA Electrosurgical GeneratorPRD-EMR-050PRD-EMR-0502025-02-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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