FDA.reportPublic FDA data

LaparoLight

Primary DI
20845854061364
Brand
LaparoLight
Company
Conmed Corporation
Model
LLVN15012
Catalog number
LLVN15012
Device description
LaparoLight Veress Needle (150 mm) Laparoscopic Solutions
Published
2020-12-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIFInsufflator, laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171139000LaparoLight Veress NeedleBuffalo Filter, LLC2017-05-18HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854061361PackageGS112In Commercial Distribution
20845854061364PrimaryGS10
00845854061360Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585406136130845854061361
2084585406136420845854061364
00845854061360008458540613608458540613600845854061360

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
12
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973031299207InsufflatorGuangdong Optomedic Technologies, Inc.HIF2026-04-22
04046955813360AESCULAPAesculap AGHIF2025-12-02
B3543000011ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000012ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000013ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000014ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000015ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000019ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000010ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
04046955813353AESCULAPAesculap AGHIF2025-05-18
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-27
04055207007822NARichard Wolf GmbHHIF2024-08-19
04055207008393NARichard Wolf GmbHHIF2024-08-19
04055207058985NARichard Wolf GmbHHIF2024-08-19
05391536920937EVA15PALLIARE LIMITEDHIF2024-07-16
10845854045633AIRSEALConmed CorporationHIF2024-03-27
00886874120699NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
B354OSLPCDG1Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG2Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG3Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG4Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG5Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG51Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG9Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
00850059707005AccuMedxAccumedx, LLCHIF2024-01-23
00850059707012AccuMedxAccumedx, LLCHIF2024-01-23
10845854045367CONMEDConmed CorporationHIF2023-12-04
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08