Cleared Traditional

K830585 - ANVIL RETRACTOR

K830585 is an FDA 510(k) clearance for ANVIL RETRACTOR, manufactured by Twin City Surgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K830585

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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

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.

Regulatory Peers - GAD Retractor

All 61
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K830585.
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46
K834181 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
K834196 · Imm Enterprises , Ltd. · Jan 1984
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983
PILLING IDENTI-LOOPS
K820377 · Narco Scientific · Mar 1982
SELF RETAINING RETRACTOR FOR HAND SURG
K820290 · The Anspach Effort, Inc. · Mar 1982