FDA.reportPublic FDA data

ETHICON

Primary DI
20705031148168
Brand
ETHICON
Company
ETHICON, LLC
Model
ESS15
Catalog number
ESS15
Device description
Cannula Reusable Knot Pusher
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963329000ETHICON ENDOSUTURE SYSTEMETHICON, Inc.1996-10-25GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031148168PackageGS112In Commercial Distribution
30705031148165PackageGS134In Commercial Distribution
10705031148161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503114816820705031148168
3070503114816530705031148165
1070503114816110705031148161

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suturing unit, reusableA manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
079402290
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031051805Coated VICRYLVCP260HVCP260H2015-09-01
10705031051874Coated VICRYLVCP267HVCP267H2015-09-01
10705031051911Coated VICRYLVCP269HVCP269H2015-09-01
10705031053038Coated VICRYLVCP417HVCP417H2015-09-01
10705031055933Coated VICRYLVCP870HVCP870H2015-09-01
10705031056213Coated VICRYLVCP958HVCP958H2015-09-01
10705031056237Coated VICRYLVCP959HVCP959H2015-09-01
10705031051744Coated VICRYLVCP232HVCP232H2015-09-01
10705031052475Coated VICRYLVCP339HVCP339H2015-09-01
10705031052499Coated VICRYLVCP340HVCP340H2015-09-01
10705031052635Coated VICRYLVCP352HVCP352H2015-09-01
10705031053823Coated VICRYLVCP497HVCP497H2015-09-01
10705031056114Coated VICRYLVCP944HVCP944H2015-09-01
10705031056121Coated VICRYLVCP945HVCP945H2015-09-01
10705031056145Coated VICRYLVCP946HVCP946H2015-09-01
10705031053519Coated VICRYLVCP468HVCP468H2015-09-01
10705031097889ETHIBOND EXCELEH7755HEH7755H2026-07-17
10705031102996ETHIBOND EXCELPE6680HPE6680H2026-07-17
10705031103085ETHIBOND EXCELPE7055HPE7055H2026-07-17
10705031238404ETHIBOND EXCELW975GW975G2026-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23