FDA.reportPublic FDA data

SurroundScope CCU

Primary DI
07290116582009
Brand
SurroundScope CCU
Company
270 SURGICAL LTD
Model
SurroundScope CCU
Catalog number
300005
Device description
Camera Control Unit for SurroundScope
Published
2021-11-25
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
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210104000SurroundScope System270surgical , Ltd.2021-07-08HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116582009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116582009072901165820097290116582009

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 610-613-5570info@270surgical.com

Regulatory Flags#

DUNS number
531854929
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290116583006SurroundScope Sterilization TraySurroundScope Sterilization Tray1002882021-11-25
07290116580005SurroundScope EndoscopeSurroundScope Endoscope3000042021-11-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
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