FDA.reportPublic FDA data

SurroundScope Endoscope

Primary DI
07290116580005
Brand
SurroundScope Endoscope
Company
270 SURGICAL LTD
Model
SurroundScope Endoscope
Catalog number
300004
Device description
SurroundScope Endoscope 90 deg
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
07290116580005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116580005072901165800057290116580005

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video laparoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
531854929
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290116583006SurroundScope Sterilization TraySurroundScope Sterilization Tray1002882021-11-25
07290116582009SurroundScope CCUSurroundScope CCU3000052021-11-25

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