FDA.reportPublic FDA data

Endo-SPONGE Pump

Primary DI
08718104890947
Brand
Endo-SPONGE Pump
Company
Meditop B.V.
Model
XS
Catalog number
5526650
Device description
The Endo-SPONGE® Pump Wound Drainage Device is a compact, portable device that delivers a controlled negative pressure to a wound bed used for wound therapy.
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082311000EXSUDEX WOUND DRAINAGE PUMPThe Medical Company2008-10-08OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718104890947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718104890947087181048909478718104890947

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, reusableAn assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and an electrically-powered vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure85 KiloPascal110 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure85 KiloPascal110 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+31348566100info@meditop.nl

Regulatory Flags#

DUNS number
387209518
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718104890954Exsudex disposable canisterExsudex Disposable canister, 300 cc with filter an55266532025-10-17
08718104890473Exsudex disposable canisterCCT 1 disposable canister with tube and luer-lock 16670-LLA2021-02-27
08718104890480Exsudex disposable canisterCCT Mini disposable canister with tube and luer-lo16690-LLA2021-02-27
08718104890084Exsudex disposable canisterNewERA I disposable canister with tube16670-NEWERA2018-02-07
08718104890091Exsudex disposable canisterNewERA II disposable canister with tube and connec16690-NEWERA2018-02-07
08718104890107Exsudex disposable canisterLarge canister with tube166702018-02-07
08718104890114Exsudex disposable canisterLarge canister with luer-lock tube16670-LL2018-02-07
08718104890121Exsudex disposable canisterLarge canister without tube16670-HZS2018-02-07
08718104890145Exsudex disposable canisterCanister 300 ml with tube and connector166902018-02-07
08718104890152Exsudex disposable canisterCanister 300 ml with tube luer-lock16690-LL2018-02-07
08718104890008Exsudex Wound Drainage pumpXS30008002016-10-26
08718104890015Exsudex Wound Drainage PumpXL30007002017-01-26
08718104890459CC1 Wound Drainage pumpXL3000700-CCT2020-12-10
08718104890466CCT Mini Wound Drainage pumpXS3000800-CCT2020-12-10
08718104890022NEWERA II Wound Drainage PumpXS3000800-IHT2016-10-26
08718104890039HALO MINI Wound Drainage PumpXS3000800-EQUINOX2016-10-26
08718104890046HALO XT Wound Drainage PumpXL3000700-HALOXT2016-10-26
08718104890053NEWERA I Wound Drainage PumpXL3000700-IHT2016-10-26
08718104890060RCI VAK Wound Drainage PumpXL3000700-RCIVAK2017-01-26
08718104890077JR VAK Wound Drainage PumpXS3000800-JRVAK2017-01-26

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