FDA.reportPublic FDA data

Insighters

Primary DI
06970831722829
Brand
Insighters
Company
Shenzhen Insighters Medical Technology Co., Ltd.
Model
iS-B12A
Device description
INSIGHTERS™ SINGLE-USE BRONCHOSCOPE/INSIGHT BIMODEL-INTEGRAL
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242793000Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.Shenzhen Insighters Medical Technology Co., Ltd.2025-05-28EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970831722829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970831722829069708317228296970831722829

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Regulatory Flags#

DUNS number
551096917
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970831723659InsightersVisible Left type 28Fr2026-04-14
06970831723666InsightersVisible Left type 32Fr2026-04-14
06970831723673InsightersVisible Left type 35Fr2026-04-14
06970831723680InsightersVisible Left type 37Fr2026-04-14
06970831723697InsightersVisible Left type 39Fr2026-04-14
06970831723703InsightersVisible Left type 41Fr2026-04-14
06970831723710InsightersVisible Right type 28Fr2026-04-14
06970831723727InsightersVisible Right type 32Fr2026-04-14
06970831723734InsightersVisible Right type 35Fr2026-04-14
06970831723741InsightersVisible Right type 37Fr2026-04-14
06970831723758InsightersVisible Right type 39Fr2026-04-14
06970831723765InsightersVisible Right type 41Fr2026-04-14
06970831723772InsightersVisible Left type B 28Fr2026-04-14
06970831723789InsightersVisible Left type B 32Fr2026-04-14
06970831723796InsightersVisible Left type B 35Fr2026-04-14
06970831723802InsightersVisible Left type B 37Fr2026-04-14
06970831723819InsightersVisible Left type B 39Fr2026-04-14
06970831723826InsightersVisible Left type B 41Fr2026-04-14
06970831723833InsightersVisible Right type B 28Fr2026-04-14
06970831723840InsightersVisible Right type B 32Fr2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920684PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920899PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920929PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920950PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926389PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926419PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926426PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926464PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926808PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926815PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926822PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926839PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926846PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926877PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926884PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926891PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926976PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926983PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926990PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927003PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927164PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927218PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826928284PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04547410524642FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
04547410524680FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
06972084140634WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28