FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333253890
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
PVK-J10
Device description
PENTAX Medical Camera Head PVK-J10
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)
EQLLaryngostroboscope
OUGMedical Device Data System
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
EQLLaryngostroboscopeEar, Nose, Throat1
OUGMedical Device Data SystemGeneral Hospital1
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220465000PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10Pentax of America, Inc.2022-11-16EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333246274Direct MarkingGS10
04961333253890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333246274049613332462744961333246274
04961333253890049613332538904961333253890

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Hydrogen Peroxide""]"

Regulatory Flags#

DUNS number
691519705
Device count
1
Serial number
true
Manufacturing date on label
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
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105732ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105749ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105473ResponderRAULAND-BORG CORPORATIONOUG2025-06-23
00841492105626ResponderRAULAND-BORG CORPORATIONOUG2025-06-23
00841492105633ResponderRAULAND-BORG CORPORATIONOUG2025-06-23
00841492101574ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492101628ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105152ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105206ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105237ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105244ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105251ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105282ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105312ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00841492105329ResponderRAULAND-BORG CORPORATIONOUG2025-06-20