FDA.reportPublic FDA data

Single Use Grasping Forceps FG

Primary DI
14953170244619
Brand
Single Use Grasping Forceps FG
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-460YR
Device description
Single Use Grasping Forceps FG
Published
2016-09-21
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
OCZEndoscopic grasping/cutting instrument, non-powered
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955063000OLYMPUS BASKET GRASPERSOlympus America, Inc.1996-01-22OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170244619PackageGS11In Commercial Distribution
04953170244612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317024461914953170244619
04953170244612049531702446124953170244612

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic grasping forceps, single-useA flexible manual device intended to be used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs or claws which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.

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
true
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
00810116023943Dornier MedTech DORNIER MEDTECH AMERICA, INC.PTS2026-04-17
00816207021744EndoTExtractorENDO-THERAPEUTICS, INC.PTS2026-03-03
00850025860628Rotatable Grasping ForcepMicro-tech UsaPTS2025-03-04
00816207021386EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
04260206311706stentfix OTSC System SetOvesco Endoscopy Usa, Inc.OCZ2024-09-13
00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219845ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
04055207041130HYSAFERichard Wolf GmbHOCZ2023-01-03
00860009064720g-Prox EZ Endoscopic GrasperUsgi Medical, Inc.OCZ2022-12-20
00860009064737g-Prox EZ Endoscopic GrasperUsgi Medical, Inc.OCZ2022-12-20
00816207020952EndoTGrasperENDO-THERAPEUTICS, INC.OCZ2022-09-21
00724995217044RaptorUS EndoscopyPTS2022-03-18
04547410454482FUJIFILMFUJIFILM CORPORATIONPTS2021-05-26
00724995180614CentraUS EndoscopyPTS2021-03-31
00724995180621CentraUS EndoscopyPTS2021-03-31
00724995180638CentraUS EndoscopyPTS2021-03-31
00724995180645CentraUS EndoscopyPTS2021-03-31
04260206311287stentfix OTSC System SetOvesco Endoscopy AGOCZ2020-09-23
00724995184063Histoguide wire guided forcepsUS EndoscopyPTS2020-04-01
00724995183653RaptorUS EndoscopyOCZ2020-03-19
00724995183653RaptorUS EndoscopyPTS2020-03-19
00724995183660RaptorUS EndoscopyOCZ2020-03-19
00724995183660RaptorUS EndoscopyPTS2020-03-19
04260206311096stentfix OTSC System SetOvesco Endoscopy AGOCZ2019-11-05
00350770927596Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10
00350770927602Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10
00350770927619Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10
00350770927626Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10
00350770927633Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10
00350770927640Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10