Cleared Traditional

K203226 - TELESCOPE 0 O 10MM WL 305MM / TELESCOPE...

K203226 is an FDA 510(k) clearance for TELESCOPE 0 O 10MM WL 305MM / TELESCOPE..., manufactured by Richard Wolf Medical Instruments Corporation. The device is a Class 2 General & Plastic Surgery device with product code GCM cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K203226 · Richard Wolf Medical Instruments Corporation · General & Plastic Surgery device
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May 2021
Decision
193d
Days
Class 2
Risk

K203226 is an FDA 510(k) clearance for the TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 1.... Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on May 14, 2021 after a review of 193 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 Richard Wolf Medical Instruments Corporation devices

FDA 510(k) Submission Details - K203226

510(k) Number K203226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2020
Decision Date May 14, 2021
Days to Decision 193 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 115d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCM Device Classification - Class 2, Special Controls

Product Code GCM Endoscope, Rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCM Endoscope, Rigid

All 9
Devices cleared under the same product code (GCM) and FDA review panel - the closest regulatory comparables to K203226.
ENDOSCOPES,10MM DIAMETER 0 DEGREES
K993103 · Richard Wolf Medical Instruments Corp. · Dec 1999
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
K962393 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
K955120 · Ethicon Endo-Surgery, Inc. · Jan 1996
ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
K935235 · Smith & Nephew Richards, Inc. · Mar 1995
KARL STORZ PLASTIC SURGERY ACCESSORIES
K945889 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
THORACOSCOPE/LAPAROSCOPE
K931954 · Surgical Technologies, Inc. · Nov 1993