Cleared Traditional

K233700 - Avicenna Roboflex (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233700 · Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi · General & Plastic Surgery device
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Aug 2024
Decision
273d
Days
Class 2
Risk

K233700 is an FDA 510(k) clearance for the Avicenna Roboflex. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi (Ankara, TR). The FDA issued a Cleared decision on August 16, 2024 after a review of 273 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi devices

Submission Details

510(k) Number K233700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2023
Decision Date August 16, 2024
Days to Decision 273 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 114d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. 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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 112
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K233700.
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K252468 · Zhejiang Geyi Medical Instrument Co., Ltd. · Dec 2025
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K253411 · Karl Storz SE & CO. KG · Nov 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
K250917 · Shenzhen Sanping Image Technology Co., Ltd. · Oct 2025