FDA.reportPublic FDA data

Signature

Primary DI
B3315851045
Brand
Signature
Company
SILEX MEDICAL, LLC
Model
5851045
Device description
Needle Nose Dissecting Forceps
Published
2018-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914910000
K933387000
K946263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914910000DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)Davol, Inc.1992-01-06GEI
K933387000BRIMFIELD PRECISION GRASPER/DISSECTORSpringfield Surgical Instruments1993-10-15GCJ
K946263000BRIMFIELD PRECISION GRASPER/DISSECTORSpringfield Surgical Instruments1995-01-26GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3315851045PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
362145604
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3315851001Signature58510012018-02-13
B331585100145Signature5851001-452018-02-13
B3315851002Signature58510022018-02-13
B331585100245Signature5851002-452018-02-13
B3315851004Signature58510042018-02-14
B3315851005Signature58510052018-02-13
B331585100545Signature5881005-452018-02-13
B3315851006Signature58510062018-02-13
B331585100645Signature5851006-452018-02-13
B3315851018Signature58510182018-02-13
B331585101845Signature5851018-452018-02-13
B3315851022Signature58510222018-02-14
B3315851024Signature58510242018-02-13
B331585102445Signature5851024-452018-02-13
B3315851028Signature58510282018-02-13
B331585102845Signature5851028-452018-02-13
B331585103245Signature5851032-452018-02-13
B3315851033Signature58510332018-02-13
B331585103345Signature5851033-452018-02-13
B3315851034Signature58510342018-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00190776422110MillenniumAvalign Technologies, Inc.GCJ2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17