FDA.reportPublic FDA data

Advanced Med-Surg Concepts

Primary DI
20841019110182
Brand
Advanced Med-Surg Concepts
Company
Advanced Med-Surg Concepts, Inc
Model
193-010C
Device description
Disposable Bipolar Forceps 5" (12.7cm) Adson, Insulated 1mm Tip and 12ft. (3.6m) Cable
Published
2016-07-10
Public version status
Update
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900533000DISPOSABLE BIPOLAR COAGULATING FORCEPSKirwan Surgical Products, Inc.1990-04-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019110185PackageGS110In Commercial Distribution
20841019110182PackageGS150In Commercial Distribution
00841019110188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911018510841019110185
2084101911018220841019110182
00841019110188008410191101888410191101880841019110188

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
177905486
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019110102Advanced Med-Surg Concepts104-0002016-07-10
00841019110119Advanced Med-Surg Concepts104-0012016-07-10
00841019110126Advanced Med-Surg Concepts104-6022016-07-10
00841019110133Advanced Med-Surg Concepts191-0032016-07-10
00841019110140Advanced Med-Surg Concepts191-003C2016-07-10
00841019110157Advanced Med-Surg Concepts191-2302016-07-10
00841019110164Advamced Med-Surg Concepts191-2402016-07-10
00841019110171Advanced Med-Surg Concepts193-0022016-07-10
00841019110188Advanced Med-Surg Concepts193-010C2016-07-10
00841019110195Advanced Med-Surg Concepts301-2032016-07-10
20841019110106Advanced Med-Surg Concepts104-0002016-07-10
30841019110110Advanced Med-Surg Concepts104-0012016-07-10
20841019110120Advanced Med-Surg Concepts104-6022016-07-10
20841019110137Advanced Med-Surg Concepts191-0032016-07-10
20841019110144Advanced Med-Surg Concepts191-003C2016-07-10
20841019110151Advanced Med-Surg Concepts191-2302016-07-10
20841019110168Advamced Med-Surg Concepts191-2402016-07-10
20841019110175Advanced Med-Surg Concepts193-0022016-07-10
20841019110199Advanced Med-Surg Concepts301-2032016-07-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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