FDA.reportPublic FDA data

Kirwan

Primary DI
00841019117552
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
30-5201AU
Device description
"Disp. Monopolar Suction Coagulator w/Resectoscope Pin, 8"" (20cm), 10 Fr., Ferrule Tip"
Published
2025-04-07
Public version status
New
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
HAMApparatus, Electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAMApparatus, ElectrosurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895337000ELECTROSURGICAL COAGULATION SUCTION TUBENew England Surgical Instrument Corp.1989-09-15HAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019117559PackageGS110In Commercial Distribution
20841019117556PackageGS150In Commercial Distribution
00841019117552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911755910841019117559
2084101911755620841019117556
00841019117552008410191175528410191175520841019117552

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Contacts#

Phone, Email table
PhoneEmail
781-834-9500mprario@ksp.com

Regulatory Flags#

DUNS number
046355210
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019123836Kirwan20-1417NSS2026-05-13
00841019123881Kirwan14-90202026-05-01
00841019123812Kirwan10-2202NSS2026-04-14
00841019123829Kirwan10-2202NSS2026-04-14
00841019123799Kirwan12-1633AUS2026-02-20
00841019123706Kirwan10-3442AUS2026-02-11
00841019123676Kirwan20-1620AUS2026-02-07
00841019123683Kirwan10-5603AUS2026-01-31
00841019123690Kirwan10-5603AUS2026-01-31
00841019123669Kirwan12-1432AUS2026-01-29
00841019123614Kirwan10-1403AUS2025-12-24
00841019123645Kirwan10-5602NSS2025-11-21
00841019123638Kirwan12-1434EAUS2025-11-19
00841019123621Kirwan20-1413EAUS2025-11-14
00841019123652Kirwan21-1411AUS2025-11-05
00841019123560Kirwan10-1603AUS2025-10-31
00841019123591Kirwan20-1618AUS2025-10-31
00841019123553Kirwan20-1613AUS2025-10-28
00841019123577Kirwan20-1621AUS2025-10-28
00841019123546Kirwan12-1400AUS2025-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019117569KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117576KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117559KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117566KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117573KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00653405002102CONMEDConmed CorporationHAM2023-11-30
20653405002106CONMEDConmed CorporationHAM2023-11-30
20653405036019ABCConmed CorporationHAM2023-10-11
14026704662118PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
34026704662112PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
19555240400854ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240401141ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400946ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400748ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
14026704662125WECKTELEFLEX INCORPORATEDHAM2019-05-08
24026704662122WECKTELEFLEX INCORPORATEDHAM2019-05-08
20888937014413LEEP Disposable Universal ElectrodesCoopersurgical, Inc.HAM2016-10-05
24026704599879WECKTELEFLEX INCORPORATEDHAM2016-09-30
04026704599875WeckTELEFLEX INCORPORATEDHAM2016-09-30
10653405002475ABCConmed CorporationHAM2016-09-24
10653405002604ABCConmed CorporationHAM2016-09-24
30653405036016ABCConmed CorporationHAM2016-09-24
30653405002103CONMEDConmed CorporationHAM2016-09-24
20653405002472ABCConmed CorporationHAM2016-09-24
20653405002601ABCConmed CorporationHAM2016-09-24
40653405036013ABCConmed CorporationHAM2016-09-24
B3964500140ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500160ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500180ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500200ESIFTT MEDICAL, INC.HAM2016-09-20