FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
00385640061469
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
FL3000-05
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092284000
K092482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092284000LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200Medical Device Resource Corp.2009-09-01MUU
K092482000TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500Shippert Medical Technologies Corp.2009-12-04MUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640061469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640061469003856400614693856400614690385640061469

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Regulatory Flags#

DUNS number
965484699
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
04260632793640TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
03760173235292DISPOSABLE FAT HARVESTING CANNULAAESTHETIC GROUPMUU2024-12-09
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31