FDA.reportPublic FDA data

Kirwan

Primary DI
10841019119140
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
30-8018
Device description
6 7/8" Insulated Angled 45 Degrees Curved Micro Dissection Needle
Published
2021-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOSElectrode, Electrosurgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895331000ELECTROSURGICAL ELECTRODENew England Surgical Instrument Corp.1989-09-15JOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019119140PackageGS15In Commercial Distribution
00841019119143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911914010841019119140
00841019119143008410191191438410191191430841019119143

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.875Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046355210
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08809295141007BIG-TIP™ RF Medical Co.,Ltd.JOS2025-09-05
08800142925092THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925108THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925115THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925122THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
04050147022751ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022768ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022775ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022782ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023543ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023550ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023567ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023574ErbeErbe Elektromedizin GmbHJOS2025-01-21
00821925008083BovieGyrus ACMI, LLCJOS2024-07-25
00821925008458BovieGyrus ACMI, LLCJOS2024-07-25
00845854030632CONMEDConmed CorporationJOS2023-12-05
08800142919206THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919213THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919220THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08809295147382V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147399V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147405V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147412V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147429V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147436V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147443V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147450V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147467V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147474V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147481V-TipRF Medical Co.,Ltd.JOS2023-10-24