Cleared Traditional

K921883 - ENDOSCOPE

K921883 is an FDA 510(k) clearance for ENDOSCOPE, manufactured by Optimed Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCM cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K921883 · Optimed Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
216d
Days
Class 2
Risk

K921883 is an FDA 510(k) clearance for the ENDOSCOPE. Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by Optimed Technologies, Inc. (Orange, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 216 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 Optimed Technologies, Inc. devices

FDA 510(k) Submission Details - K921883

510(k) Number K921883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1992
Decision Date November 23, 1992
Days to Decision 216 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
86d slower than avg
Panel avg: 130d · This submission: 216d
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 K921883.
KARL STORZ PLASTIC SURGERY ACCESSORIES
K945889 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
THORACOSCOPE/LAPAROSCOPE
K931954 · Surgical Technologies, Inc. · Nov 1993
PRESSURE TURING AND ACCESSORIES
K925918 · Applied Medical Resources · Feb 1993
LAMANO DIRECTORS
K894592 · Marlo Surgical Technology · Sep 1989
RIGID ENDOSCOPE
K853514 · American Edwards Laboratories · Oct 1985