Cleared Traditional

K993738 - DISPOS-A-SCOPE

K993738 is an FDA 510(k) clearance for DISPOS-A-SCOPE, manufactured by Dispos-A-Scope. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K993738 · Dispos-A-Scope · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
63d
Days
Class 2
Risk

K993738 is an FDA 510(k) clearance for the DISPOS-A-SCOPE. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Dispos-A-Scope (Lewiston, US). The FDA issued a Cleared decision on January 6, 2000 after a review of 63 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 Dispos-A-Scope devices

FDA 510(k) Submission Details - K993738

510(k) Number K993738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date January 06, 2000
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FER Device Classification - Class 2, Special Controls

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 - FER Anoscope And Accessories

All 12
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K993738.
GELPOINT PATH
K110792 · Applied Medical Resources Corp. · May 2011
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K060623 · Cook Ireland, Ltd. · Sep 2006
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · Welch Allyn, Inc. · Feb 1981
ANOSCOPE, OPTIC, FIBER
K770906 · Welch Allyn, Inc. · Jun 1977