FDA.reportPublic FDA data

Kirwan

Primary DI
00841019123652
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
21-1411AUS
Device description
"Reusable Bipolar Forceps: Laser Mark ""AS00"" on Cup (Special)"
Published
2025-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811820000BIPOLAR COAGULATING FORCEPSNew England Surgical Instrument Corp.1981-07-28GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841019123652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019123652008410191236528410191236520841019123652

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
046355210
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
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
00841019123560Kirwan10-1603AUS2025-10-31
00841019123591Kirwan20-1618AUS2025-10-31
00841019123553Kirwan20-1613AUS2025-10-28
00841019123577Kirwan20-1621AUS2025-10-28
00841019123546Kirwan12-1400AUS2025-10-11
00841019123102Kirwan22-1654PL2025-10-01

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Primary DI, Brand, Company table
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