Cleared Traditional

K820291 - KNEE SUPPORT FOR X-RAY & SURGERY

K820291 is the FDA 510(k) clearance for KNEE SUPPORT FOR X-RAY & SURGERY by The Anspach Effort, Inc.. It is a Class 1 General & Plastic Surgery device (product code FWZ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K820291 · The Anspach Effort, Inc. · General & Plastic Surgery device
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Mar 1982
Decision
30d
Days
Class 1
Risk

K820291 is an FDA 510(k) clearance for the KNEE SUPPORT FOR X-RAY & SURGERY. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982 after a review of 30 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K820291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1982
Decision Date March 05, 1982
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 K820291.
ACUFEX UNIVERSAL LEG HOLDER
K830707 · Acufex Microsurgical, Inc. · May 1983
ARTHROSCOPY SYSTEM LEG HOLDER
K821029 · Zimmer, Inc. · Apr 1982
ANTHROSCOPIC SURGICAL TABLE
K820289 · The Anspach Effort, Inc. · Apr 1982
O.R. ARMBOARD COVER
K813030 · Tecnol New Jersey Wound Care, Inc. · Jan 1982
TABLE, HAND SURGI
K760456 · Stryker Corp. · Nov 1976