FDA.reportPublic FDA data

Disposable Distal Cap

Primary DI
06932503563444
Brand
Disposable Distal Cap
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
VC11157
Device description
Visor type of Disposable Distal Cap, the maximum outer diameter of product is 15.7mm, the length from distal end of endoscopes is 7mm, the diameter of the side hole is 3mm, the total length is 17mm and the diameter of attaching endoscopic distal end is 13.4mm-13.9mm
Published
2025-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K243388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243388000Disposable Distal CapMicro-Tech (Nanjing) Co., Ltd.2025-06-27FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503563441PackageGS110In Commercial Distribution
26932503563448PackageGS110In Commercial Distribution
06932503563444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356344116932503563441
2693250356344826932503563448
06932503563444069325035634446932503563444

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope distal observation spacer, single-useA short, light-penetrating cap designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation, by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap; it does not have anchoring capabilities (i.e., not an anchoring cuff). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Millimeter
Outer Diameter15.7Millimeter

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932503563857Additional Working ChannelEZS011752026-09-30
06932503563864Additional Working ChannelEZS114752026-09-30
06932503563871Additional Working ChannelEZS217802026-09-30
06932503516563Sphincterotome / short-wire compatibleRDSP-0230-231-22026-06-27
06932503540353Disposable Biopsy Forceps1005751005752020-03-23
06932503540360Disposable Biopsy Forceps1005761005762020-03-23
06932503540377Disposable Biopsy Forceps1005771005772020-03-23
06932503540384Disposable Biopsy Forceps1005781005782020-03-23
06932503510219Pulmonary Hydro-Slide GuidewireGW-35/182026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireGW-35/262026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08

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08809882470428Controller BEndoRobotics Co., Ltd.FDS2026-10-16
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