Cleared Traditional

K861017 - GALENICA'S DISPOSABLE ANOSCOPES

K861017 is the FDA 510(k) clearance for GALENICA'S DISPOSABLE ANOSCOPES by Galenica Enterprises, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FER) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K861017 · Galenica Enterprises, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
87d
Days
Class 2
Risk

K861017 is an FDA 510(k) clearance for the GALENICA'S DISPOSABLE ANOSCOPES. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Galenica Enterprises, Inc. (Quebec Canada J7e 4h7, CA). The FDA issued a Cleared decision on June 13, 1986 after a review of 87 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 Galenica Enterprises, Inc. devices

Submission Details

510(k) Number K861017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date June 13, 1986
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K861017.
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