FDA.reportPublic FDA data

SOLOS

Primary DI
00866370000343
Brand
SOLOS
Company
SOLOS ENDOSCOPY, INC.
Model
GS5000
Device description
Spatula Suction Coagulator, 5mm
Published
2017-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925114000LAPAROSCOPIC INSTRUMENTSEndo Technic Corp.1994-02-28HFI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866370000343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866370000343008663700003438663700003430866370000343

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
625281332
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862311000403SOLOSGS10022017-05-26
00862311000410SOLOSGS10002017-05-26
00862311000427SOLOSGS15002017-05-26
00862311000434SOLOSGU15402017-05-26
00862311000441SOLOSGI11902017-05-26
00862311000458SOLOSGS11002017-05-26
00862311000465SOLOSGS52502017-05-26
00862311000472SOLOSGS1365R2017-05-26
00862311000489SOLOSGS1000R2017-05-26
00862311000496SOLOSGI10702017-05-26
00866370000305SOLOSGS1305R2017-01-27
00866370000312SOLOSGI10502017-01-27
00866370000329SOLOSGI10552017-01-27
00866370000336SOLOSGS13402017-01-27
00866370000350SOLOSGS52002017-01-27
00866370000367SOLOSGI10652017-01-27
00866370000374SOLOSGS13652017-01-27
00866370000381SOLOSGS13052017-01-27
00866370000398SOLOSGS1000DN2017-01-27
00841019112083SOLOSGS60052016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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