Cleared Traditional

K931837 - ACUFEX STERILE DRILLS

K931837 is an FDA 510(k) clearance for ACUFEX STERILE DRILLS, manufactured by Acufex Microsurgical, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K931837 · Acufex Microsurgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
269d
Days
Class 1
Risk

K931837 is an FDA 510(k) clearance for the ACUFEX STERILE DRILLS. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 269 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K931837

510(k) Number K931837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date January 07, 1994
Days to Decision 269 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 122d · This submission: 269d
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 75
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K931837.
SODEM POWER SYSTEM
K935567 · Sodemsystems · Jan 1994
OSTEON ADAPTOR/CRADLE
K930319 · United American Medical Co., Inc. · Jan 1994
POWERED SURGICAL INSTRUMENT ACCESSORY
K930363 · Intenn Engineering, Inc. · Jan 1994
ES-100 ACCESSORIES
K932261 · Elekta Instruments, Inc. · Jan 1994
HHI ELECTRIC CONSOLE #875-000
K922056 · H&H Instruments · Sep 1992
CKS OSCILLATING SAW BLADE
K921131 · Techmedica, Inc. · Jun 1992
K931837 · ACUFEX STERILE DRILLS
Download PDF Acufex Microsurgical,…