FDA.reportPublic FDA data

Surgineedle

Primary DI
20884521080802
Brand
Surgineedle
Company
Covidien LP
Model
172015
Device description
Insufflation Needle
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHOpneumoperitoneum needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHOPneumoperitoneum NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863330000DISPOSABLE PNEUMOPERITONEUM NEEDLEUnited States Surgical, A Division of Tyco Healthc1986-10-02FHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521080802PackageGS112In Commercial Distribution
10884521080805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108080220884521080802
1088452108080510884521080805

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08
10884521543867SigniaSIGSBCHGR2017-08-01
10884521128927SonicisionSCST2016-09-24
10884521543829SigniaSIGADAPTSHORT2017-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.FHO2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.FHO2024-05-23
00850059707005AccuMedxAccumedx, LLCFHO2024-01-23
00850059707012AccuMedxAccumedx, LLCFHO2024-01-23
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
00858690006990INSUFFLATION NEEDLE,15CMRANFAC CORP.FHO2018-03-02
20858690006994INSUFFLATION NEEDLE,15CMRANFAC CORP.FHO2018-03-02
04714127862026Veress NeedleUNIMAX MEDICAL SYSTEMS INC.FHO2017-06-19
00821925002616THL Gyrus ACMI, LLCFHO2017-05-11
00858690006204INSUFFLATION NEEDLE,12CMRANFAC CORP.FHO2017-05-08
20858690006208INSUFFLATION NEEDLE,12CMRANFAC CORP.FHO2017-05-08
04714127862002Veress NeedleUNIMAX MEDICAL SYSTEMS INC.FHO2017-01-09
24714127862006Veress NeedleUNIMAX MEDICAL SYSTEMS INC.FHO2017-01-09
06955797740018Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
06955797740025Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
16955797740015Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
16955797740022Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd.FHO2016-12-22
20884521080819SurgineedleCovidien LPFHO2016-10-20
10884521080812SurgineedleCovidien LPFHO2016-10-20
00821925001527USA SeriesGyrus ACMI, LLCFHO2016-10-14
00821925008915USA SeriesGyrus ACMI, LLCFHO2016-10-14
04055207039755NARichard Wolf GmbHFHO2016-09-27
04055207043097NARichard Wolf GmbHFHO2016-09-27
04055207043103NARichard Wolf GmbHFHO2016-09-27
04055207057988NARichard Wolf GmbHFHO2016-09-27
04055207057995NARichard Wolf GmbHFHO2016-09-27
10884521080805SurgineedleCovidien LPFHO2016-09-24
20653405046032CORE DYNAMICSConmed CorporationFHO2016-09-24
20653405046049CORE DYNAMICSConmed CorporationFHO2016-09-24