Cleared Traditional

K994130 - RECTOSIGHT RS 300-04

K994130 is an FDA 510(k) clearance for RECTOSIGHT RS 300-04, manufactured by Sightline Technologies , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K994130 · Sightline Technologies , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
206d
Days
Class 2
Risk

K994130 is an FDA 510(k) clearance for the RECTOSIGHT RS 300-04. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Sightline Technologies , Ltd. (Ginot, Shomron, IL). The FDA issued a Cleared decision on June 30, 2000 after a review of 206 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 Sightline Technologies , Ltd. devices

FDA 510(k) Submission Details - K994130

510(k) Number K994130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date June 30, 2000
Days to Decision 206 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
76d slower than avg
Panel avg: 130d · This submission: 206d
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 K994130.
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