Cleared Traditional

K083840 - MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE

K083840 is an FDA 510(k) clearance for MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE, manufactured by Msi Medserv International Deutschland GmbH. The device is a Class 2 Gastroenterology & Urology device with product code GCM cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K083840 · Msi Medserv International Deutschland GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
278d
Days
Class 2
Risk

K083840 is an FDA 510(k) clearance for the MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE. Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by Msi Medserv International Deutschland GmbH (Pfullendorf, DE). The FDA issued a Cleared decision on September 28, 2009 after a review of 278 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 Msi Medserv International Deutschland GmbH devices

FDA 510(k) Submission Details - K083840

510(k) Number K083840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date September 28, 2009
Days to Decision 278 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 130d · This submission: 278d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCM Endoscope, Rigid

All 10
Devices cleared under the same product code (GCM) and FDA review panel - the closest regulatory comparables to K083840.
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
K203226 · Richard Wolf Medical Instruments Corporation · May 2021
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