Cleared Traditional

K961695 - ENDO-TECH LTD., TIPS

K961695 is an FDA 510(k) clearance for ENDO-TECH LTD., manufactured by Ratio Design Lab. The device is a Class 2 Obstetrics & Gynecology device with product code HFG cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K961695 · Ratio Design Lab · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
61d
Days
Class 2
Risk

K961695 is an FDA 510(k) clearance for the ENDO-TECH LTD., TIPS. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.

Submitted by Ratio Design Lab (Alpheretta, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology 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.

FDA 510(k) Submission Details - K961695

510(k) Number K961695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date July 01, 1996
Days to Decision 61 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 161d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFG Device Classification - Class 2, Special Controls

Product Code HFG Coagulator, Laparoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFG Coagulator, Laparoscopic, Unipolar (and Accessories)

All 10
Devices cleared under the same product code (HFG) and FDA review panel - the closest regulatory comparables to K961695.
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K961695 · ENDO-TECH LTD., TIPS
Download PDF FDA Summary Ratio Design Lab