Cleared Traditional

K884862 - ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE

K884862 is an FDA 510(k) clearance for ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE, manufactured by Anchor Products Co.. The device is a Class 1 General & Plastic Surgery device with product code GES cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K884862 · Anchor Products Co. · General & Plastic Surgery device
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Dec 1988
Decision
36d
Days
Class 1
Risk

K884862 is an FDA 510(k) clearance for the ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Anchor Products Co. (Addison, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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.

FDA 510(k) Submission Details - K884862

510(k) Number K884862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date December 27, 1988
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

GES Device Classification - Class 1, General Controls

Product Code GES Blade, Scalpel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GES Blade, Scalpel

All 47
Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K884862.
SCALPEL BLADE REMOVER (BLADEGARD)
K915119 · Intergrated Visual, Inc. · May 1992
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
STERILE CARBON STEEL SURGICAL BLADE
K900266 · Rahn Laboratories · Mar 1990
SURGICAL BLADE
K881638 · Far East Intl. Trading Corp. · Jun 1988
SURGICAL BLADES
K880244 · Ailee C/O Havel'S, Inc. · Feb 1988
NINJA SCALPEL
K873493 · Primrose Medical, Inc. · Sep 1987
K884862 · ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
Download PDF Anchor Products Co.