FDA.reportPublic FDA data

PENTAX

Primary DI
04961333224548
Brand
PENTAX
Company
HOYA CORPORATION
Model
KW2218CS
Device description
FORCEPS WITH WINDOW
Published
2017-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850020000PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23Pentax Precision Instrument Corp.1985-07-09FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333083404Direct MarkingGS10
04961333224548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333083404049613330834044961333083404
04961333224548049613332245484961333224548

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Sound Waves"", ""Moist Heat or Steam Sterilization""]"
Sound Waves;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691519705
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15