FDA.reportPublic FDA data

Single Use Reloadable Clip Applicator

Primary DI
14953170390736
Brand
Single Use Reloadable Clip Applicator
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
HX-810UR
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183590000Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short ClipOlympus Medical Systems Corp.2019-08-01PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170390736PackageGS110In Commercial Distribution
04953170390739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317039073614953170390736
04953170390739049531703907394953170390739

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344203437MEDLINEMEDLINE INDUSTRIES, INC.PKL2026-04-23
10197344203444MEDLINEMEDLINE INDUSTRIES, INC.PKL2026-04-23
00860014822704EndoFix Tissue Fixation DeviceEndofix Medical Technologies, Inc.PKL2026-02-02
00860014822711Secure Suture Locking DeviceEndofix Medical Technologies, Inc.PKL2026-02-02
46932503530819Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530833Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530840Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530864Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530871Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530895Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530918Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530932Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530956Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530970Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530994Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535012Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535029Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535036Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535043Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535050Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530666RiteClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-02
46932503530727RiteClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-02
46932503530390SureClip(®MINI) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530413SureClip(®MINI) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530420SureClip(®) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530444SureClip(®) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530451SureClip(®PLUS) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530468SureClip(®PLUS) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530512SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530529SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30