FDA.reportPublic FDA data

INSPIRA

Primary DI
04961333251896
Brand
INSPIRA
Company
HOYA CORPORATION
Model
EC38-i20cL
Device description
PENTAX Medical Video Colonoscope EC38-i20cL
Published
2023-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231249000PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc.2023-07-28PEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333251896Direct MarkingGS10
04961333252169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333251896049613332518964961333251896
04961333252169049613332521694961333252169

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant;Liquid Chemical

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925153OPTIVISTAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925245DEFINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925450IMAGINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925696PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925849PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925856PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925894PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925900PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826927447PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25