FDA.reportPublic FDA data

Footswitch

Primary DI
05060359560100
Brand
Footswitch
Company
CREO MEDICAL LIMITED
Model
7-PG1-132
Catalog number
7-PG1-132
Device description
Footswitch accessory for use only with the CROMA Electrosurgical Generators.
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171983000Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.2017-08-17KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060359560100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060359560100050603595601005060359560100

GMDN Terms#

Term, Definition table
TermDefinition
Microwave/electrosurgical system generatorAn electrically-powered component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
733853373
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05060359560490MicroBlate 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06959664912119NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664919118NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934036NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934067NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934074NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934098NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17