Cleared Traditional

K830585 - ANVIL RETRACTOR (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K830585 · Twin City Surgical, Inc. · General & Plastic Surgery device
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May 1983
Decision
93d
Days
Class 1
Risk

K830585 is an FDA 510(k) clearance for the ANVIL RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Twin City Surgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Twin City Surgical, Inc. devices

Submission Details

510(k) Number K830585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date May 27, 1983
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 114d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
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.