Cleared Traditional

K830707 - ACUFEX UNIVERSAL LEG HOLDER

K830707 is the FDA 510(k) clearance for ACUFEX UNIVERSAL LEG HOLDER by Acufex Microsurgical, Inc.. It is a Class 1 General & Plastic Surgery device (product code FWZ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K830707 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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May 1983
Decision
56d
Days
Class 1
Risk

K830707 is an FDA 510(k) clearance for the ACUFEX UNIVERSAL LEG HOLDER. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Walker, US). The FDA issued a Cleared decision on May 2, 1983 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K830707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1983
Decision Date May 02, 1983
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWZ Operating Room Accessories Table Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - FWZ Operating Room Accessories Table Tray

All 18
Devices cleared under the same product code (FWZ) and FDA review panel - the closest regulatory comparables to K830707.
ULNAR NERVE PROTECTOR
K840421 · Devon Industries, Inc. · Mar 1984
DEVON HEAD REST
K840422 · Devon Industries, Inc. · Mar 1984
SHUTT UNIVERSAL STRESS POST
K833624 · Concept, Inc. · Nov 1983
ARTHROSCOPY SYSTEM LEG HOLDER
K821029 · Zimmer, Inc. · Apr 1982
ANTHROSCOPIC SURGICAL TABLE
K820289 · The Anspach Effort, Inc. · Apr 1982
KNEE SUPPORT FOR X-RAY & SURGERY
K820291 · The Anspach Effort, Inc. · Mar 1982