Cleared Traditional

K811965 - VISITEC NEEDLE RANGE (GASTERUROLOGY)

K811965 is an FDA 510(k) clearance for VISITEC NEEDLE RANGE (GASTERUROLOGY), manufactured by Visitec Co.. The device is a Class 1 General & Plastic Surgery device with product code FHR cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K811965 · Visitec Co. · General & Plastic Surgery device
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Aug 1981
Decision
46d
Days
Class 1
Risk

K811965 is an FDA 510(k) clearance for the VISITEC NEEDLE RANGE (GASTERUROLOGY). Classified as Needle, Gastro-urology (product code FHR), Class I - General Controls.

Submitted by Visitec Co. (Walker, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Visitec Co. devices

FDA 510(k) Submission Details - K811965

510(k) Number K811965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1981
Decision Date August 25, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

FHR Device Classification - Class 1, General Controls

Product Code FHR Needle, Gastro-urology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.