FDA.reportPublic FDA data

AP50/30

Primary DI
00852588007229
Brand
AP50/30
Company
LEXION MEDICAL, LLC
Model
4100
Catalog number
4100
Device description
High Flow Insufflator
Published
2020-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HIFInsufflator, Laparoscopic
OSVInsufflator, Endoscopic Vessel Harvesting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HIFInsufflator, LaparoscopicObstetrics/Gynecology2
OSVInsufflator, Endoscopic Vessel HarvestingObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170799000
K191780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170799000AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC2017-11-14HIF
K191780000AP50/30 Insufflator with Insuflow PortLexion Medical, LLC2019-08-28HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852588007229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852588007229008525880072298525880072290852588007229

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic insufflatorA mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
848693730
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852588007014Insuflow6198NS6198NS2017-02-15
00852588007021INSUFLOWPP1000NSPP1000NS2017-02-15
00852588007069VERYCLEAR151515152017-02-15
00852588007083INSUFLOW SYNERGY PORT199119912017-02-15
00852588007090INSUFLOW SYNERGY XL PORT 1991-81991-82017-02-15
00852588007106INSUFLOW SYNERGY XL PORT1991-101991-102017-02-15
00852588007113INSUFLOW SYNERGY XL PORT1991-121991-122017-02-15
00852588007120INSUFLOW SYNERGY XL PORT1991-8B1991-8B2017-02-15
00852588007137iNSUFLOW SYNERGY XL PORT1991-10B1991-10B2017-02-15
00852588007144INSUFLOW SYNERGY XL PORT1991-12B1991-12B2017-02-15
00852588007243Standard filtered tube set4100-SHT4100-SHT2020-11-05
00852588007151Insuflow Port4100-54100-52020-11-05
00852588007168Insuflow Port4100-84100-82020-11-05
00852588007175Insuflow Port4100-8B4100-8B2020-11-05
00852588007182Insuflow Port4100-104100-102020-11-05
00852588007199Insuflow Port4100-10B4100-10B2020-11-05
00852588007205Insuflow Port4100-124100-122020-11-05
00852588007212Insuflow Port4100-12B4100-12B2020-11-05
00852588007236Insuflow Port4100-5B4100-5B2020-11-05
00852588007038INSUFLOW6198M6198M2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28