FDA.reportPublic FDA data

InnoClip

Primary DI
14717480902368
Brand
InnoClip
Company
TAIWAN SURGICAL CORPORATION
Model
DC5T1-BX
Device description
Disposable Clip Applier, 5mm, Titanium, ML, 10 clips
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDOApplier, Surgical, Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202994000InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation2022-01-04FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14717480902368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1471748090236814717480902368

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657134172
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04717480900374Taiwan SurgicalTSR-120-R2023-08-02
04717480902347InnoClipRC5T1-B62023-07-11
04717480902354InnoClipRC5T1-BX2023-07-11
04717480906024SkinPlusDP0S1-SR2023-07-11
04717480906031SkinPlusDP0S1-SW2023-07-11
14717480902016InnoClipTDC-10-ML2023-07-11
14717480902023InnoClipTDC-10-L2023-07-11
14717480902306InnoClipTRC-H00002023-07-11
14717480902375InnoClipDC5T1-B62023-07-11
04717480900008Inno-PortDT501-7B2023-06-07
04717480900015Inno-PortDT501-7Q2023-06-07
04717480900022Inno-PortDT501-XB2023-06-07
04717480900039Inno-PortDT501-XQ2023-06-07
04717480900046Inno-PortDT501-7L2023-06-07
04717480900053Inno-PortDT501-7P2023-06-07
04717480900060Inno-PortDT501-XL2023-06-07
04717480900077Inno-PortDT501-XP2023-06-07
04717480900084Inno-PortDT501-712023-06-07
04717480900121Inno-PortDTW01-XB2023-06-07
04717480900138Inno-PortDTW01-XQ2023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704921335WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921342WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921359WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921366WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921373WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921380WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921403WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921410WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921427WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921434WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921441WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921458WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921571WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921588WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921595WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921618WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921625WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921632WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921663WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921670WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921687WECKTELEFLEX INCORPORATEDGDO2026-03-10
B382SD5715300Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD87531140Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD32155560Surgical DirectSurgical Direct, Inc.GDO2026-02-26
B382SD32155520Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155530Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155540Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155550Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32152540Surgical DirectSurgical Direct, Inc.GDO2026-02-20
14026704935496WECKTELEFLEX INCORPORATEDGDO2026-02-06