Cleared Traditional

K252457 - Disposable Distal End Tape Hood (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252457 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Gastroenterology & Urology device
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Jan 2026
Decision
178d
Days
Class 2
Risk

K252457 is an FDA 510(k) clearance for the Disposable Distal End Tape Hood. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Shanghai SeeGen Photoelectric Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 30, 2026 after a review of 178 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai SeeGen Photoelectric Technology Co., Ltd. devices

Submission Details

510(k) Number K252457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2025
Decision Date January 30, 2026
Days to Decision 178 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 130d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 110
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K252457.
ROBOPERA (ER-R-002)
K244029 · Endorobotics Co., Ltd. · Sep 2025
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Colonovideoscope (CF-EZ1500DL)
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PENTAX Medical Video Colonoscope (EC38-i20cWL)
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GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
K242325 · Actuated Medical, Inc. · Oct 2024
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K232043 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Feb 2024