FDA.reportPublic FDA data

N/A

Primary DI
00885825015602
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
225370
Device description
Soft Tissue Ablator 90 Electrode w/Integrated Handpiece
Published
2016-09-23
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012695000VANGUARD REPROCESSED ARTHROSCOPIC WANDSVanguard Medical Concepts, Inc.2001-10-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30885825015603PackageGS14In Commercial Distribution
00885825015602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088582501560330885825015603
00885825015602008858250156028858250156020885825015602

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, reprocessedA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps) which may include a lumen for suction/irrigation; it does not include a handpiece/housing with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature025 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
00887482149584BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149591BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149607BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149614BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149621BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149638BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149645BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149652BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149669BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149676BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149683BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
00887482149690BovieASPEN SURGICAL PRODUCTS, INC.GEI2024-08-26
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800020104304Density Main bodyJeisys Medical Inc.GEI2023-08-29
07613327413281Connected OR HubSTRYKER CORPORATIONHRX2023-07-26