Cleared Traditional

K833859 - TAMPONADE BALLOON CUFF

K833859 is an FDA 510(k) clearance for TAMPONADE BALLOON CUFF, manufactured by American Endoscopy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCP cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K833859 · American Endoscopy, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
57d
Days
Class 2
Risk

K833859 is an FDA 510(k) clearance for the TAMPONADE BALLOON CUFF. Classified as Endoscope, Ac-powered And Accessories (product code GCP), Class II - Special Controls.

Submitted by American Endoscopy, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Endoscopy, Inc. devices

FDA 510(k) Submission Details - K833859

510(k) Number K833859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date January 03, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCP Device Classification - Class 2, Special Controls

Product Code GCP Endoscope, Ac-powered And Accessories
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 - GCP Endoscope, Ac-powered And Accessories

All 9
Devices cleared under the same product code (GCP) and FDA review panel - the closest regulatory comparables to K833859.
PORGES UNIVERSAL HANDLES
K896505 · Porges Corp. · Jan 1990
MODEL 6500 MERCURY ARC LIGHT SOURCE
K896008 · Medical Dynamics, Inc. · Dec 1989
STEERABLE CATHETER SYSTEM
K862424 · Endovations · Sep 1986
CCD ENDOSCOPE AND ATTACHMENTS
K801247 · Welch Allyn, Inc. · Jul 1980
ENDOSCOPE AND ACCESSORIES
K790071 · Olympus Corp. · Apr 1979
FIBEO OPTICS ILLUM. SYSTEM
K771918 · Propper Mfg. Co., Inc. · Oct 1977