Cleared Traditional

K962022 - POWERCUT GOLD SURGICAL SYSTEM

K962022 is an FDA 510(k) clearance for POWERCUT GOLD SURGICAL SYSTEM, manufactured by Baxter Healthcare Corp. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K962022 · Baxter Healthcare Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
74d
Days
Class 1
Risk

K962022 is an FDA 510(k) clearance for the POWERCUT GOLD SURGICAL SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 5, 1996 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K962022

510(k) Number K962022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1996
Decision Date August 05, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 52
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K962022.
SYNTHES STERILE DRILL BITS
K962913 · Synthes (Usa) · Nov 1996
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
K962800 · Stryker Instruments · Sep 1996
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
K962215 · U.S. Medical Products, Inc. · Aug 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · Stryker Corp. · Jul 1996
CEMENT AND BONE REMOVAL KIT
K961759 · Maillefer Instruments S.A. · Jun 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · Exactech, Inc. · Apr 1996