FDA.reportPublic FDA data

SECQURE Ultimate

Primary DI
00863634000446
Brand
SECQURE Ultimate
Company
SECQURE SURGICAL, CORP.
Model
CQ5462ULT
Device description
Dilating Tip Trocar, Threaded Cannula, 12mm x 100mm
Published
2017-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K081398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081398000ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIESAdvanced Medical Innovations, Inc.2009-02-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863634000446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863634000446008636340004468636340004460863634000446

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079554198
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863634000408SECQURE Ultimate CQ5560ULT2017-09-19
00863634000415SECQURE UltimateCQ5562ULT2017-09-19
00863634000422SECQURE UltimateCQ5465ULT2017-09-19
00863634000439SECQURE Ultimate CQ5460ULT2017-09-19
00863634000453SECQURE UltimateCQ5563ULT2017-09-19
B092CS250CQ'ENCE Circular Stapler 25mmCS25CS252017-10-25
B092CS280CQ'ENCE Circular Stapler 28mmCS28CS282017-10-25
B092CS310CQ'ENCE Circular Stapler 31mmCS31CS312017-10-25
B092CS340CQ'ENCE Circular Stapler 34mmCS34CS342017-10-25
00863634000484SECQURE UltimateCQ3850ULT2017-09-19
00863634000491SECQURE UltimateCQ3851ULT2017-09-19
00863634000460SECQURE UltimateCQ3442ULT2017-09-19
00863634000477SECQURE UltimateCQ3443ULT2017-09-19

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Primary DI, Brand, Company table
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