Cleared Traditional

K974025 - ANSPACH SHIELDED ATTACHMENT

K974025 is an FDA 510(k) clearance for ANSPACH SHIELDED ATTACHMENT, manufactured by The Anspach Effort, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K974025 · The Anspach Effort, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
256d
Days
Class 1
Risk

K974025 is an FDA 510(k) clearance for the ANSPACH SHIELDED ATTACHMENT. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 256 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K974025

510(k) Number K974025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1997
Decision Date July 06, 1998
Days to Decision 256 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 115d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

GFF Device Classification - Class 1, General Controls

Product Code GFF Bur, Surgical, General & Plastic Surgery
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 - GFF Bur, Surgical, General & Plastic Surgery

All 8
Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K974025.
SURGICAL BUR
K950449 · Transidyne General Corp. · Mar 1995
MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS
K894438 · Micro-Aire Surgical Instruments, Inc. · Aug 1989
DANEK IRRIGATING BURR (DIB) SET
K890090 · Danek Medical, Inc. · Jan 1989
SURGICAL BURS
K880859 · New England Surgical Instrument Corp. · Mar 1988
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · Micro-Aire Surgical Instruments, Inc. · Aug 1986
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · Micro-Aire Surgical Instruments, Inc. · Mar 1985