Cleared Traditional

K200770 - Mini PCNL-System (FDA 510(k) Clearance)

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

K200770 · Trokamed GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
492d
Days
Class 2
Risk

K200770 is an FDA 510(k) clearance for the Mini PCNL-System. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Trokamed GmbH (Geisingen, DE). The FDA issued a Cleared decision on July 30, 2021 after a review of 492 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Trokamed GmbH devices

Submission Details

510(k) Number K200770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2020
Decision Date July 30, 2021
Days to Decision 492 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
362d slower than avg
Panel avg: 130d · This submission: 492d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 100
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K200770.
CVAC Aspiration System
K260965 · Calyxo, Inc. · Apr 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
K260521 · Zhuhai Pusen Medical Technology Co., Ltd. · Apr 2026
Prodeon Urethral Sheath System
K252572 · Prodeon Medical, Inc. · Oct 2025
Single Use Suction-Evacuation Ureteral Access Sheath
K250128 · Anhui Happiness Workshop Medical Instruments Co., Ltd. · Sep 2025
Ureteral Access Sheath
K250132 · Zhejiang Yigao Medical Technology Co., Ltd. · Sep 2025
Single-use Ureteral Access Sheath
K250695 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Jul 2025