Cleared Traditional

K950712 - PORTABLE ENDOSCOPY SYSTEM

K950712 is an FDA 510(k) clearance for PORTABLE ENDOSCOPY SYSTEM, manufactured by Laser Optik Systeme GmbH & Co. KG. The device is a Class 2 Gastroenterology & Urology device with product code GCM cleared through the Traditional 510(k) pathway after a 455-day FDA review.

K950712 · Laser Optik Systeme GmbH & Co. KG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
455d
Days
Class 2
Risk

K950712 is an FDA 510(k) clearance for the PORTABLE ENDOSCOPY SYSTEM. Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on May 14, 1996 after a review of 455 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 Laser Optik Systeme GmbH & Co. KG devices

FDA 510(k) Submission Details - K950712

510(k) Number K950712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date May 14, 1996
Days to Decision 455 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 130d · This submission: 455d
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 K950712.
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