FDA.reportPublic FDA data

Kirwan

Primary DI
00841019115756
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
19-8010C
Device description
"8 1/2"" Disposable Monopolar Potts-Smith, Insulated, 1.5mm Tip with 10ft. Cord"
Published
2025-04-04
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872271000VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPSNew England Surgical Instrument Corp.1987-06-26GEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019115753PackageGS110In Commercial Distribution
20841019115750PackageGS150In Commercial Distribution
00841019115756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911575310841019115753
2084101911575020841019115750
00841019115756008410191157568410191157560841019115756

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.5Inch

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
00841019123867Kirwan12-1400AUS2026-07-24
00841019123959Kirwan12-1237NSS2026-07-25
00841019123966Kirwan12-1237NSS2026-07-25
00841019123973Kirwan12-1237NSS2026-07-25
00841019123980Kirwan12-1237NSS2026-07-25
00841019123997Kirwan12-1237NSS2026-07-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934891SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935362SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935379SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935546SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935553SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935560SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935584SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935591SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935669SURGIPROSSurgipros, LLCGEN2026-07-30
B382SD919327220Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919327230Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919523070Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919523080Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD920277290Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD920759990Surgical DirectSurgical Direct, Inc.GEN2026-07-29
00190776422158MillenniumAvalign Technologies, Inc.GEN2026-07-28
00190776422165MillenniumAvalign Technologies, Inc.GEN2026-07-28
00198506093319ELMED INCORPORATEDELMED INCORPORATEDGEN2026-07-28
B382SD375304150Surgical DirectSurgical Direct, Inc.GEN2026-07-28
B382SD375304200Surgical DirectSurgical Direct, Inc.GEN2026-07-28
B382SD9028541110Surgical DirectSurgical Direct, Inc.GEN2026-07-28