Cleared Traditional

K871925 - STRAIGHT CUP CURRETTE

K871925 is an FDA 510(k) clearance for STRAIGHT CUP CURRETTE, manufactured by Arthropedics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K871925 · Arthropedics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
14d
Days
Class 1
Risk

K871925 is an FDA 510(k) clearance for the STRAIGHT CUP CURRETTE, 1.7MM. Classified as Curette, Surgical, General Use (product code FZS), Class I - General Controls.

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 14 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.

View all Arthropedics, Inc. devices

FDA 510(k) Submission Details - K871925

510(k) Number K871925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1987
Decision Date June 01, 1987
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

FZS Device Classification - Class 1, General Controls

Product Code FZS Curette, Surgical, General Use
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 - FZS Curette, Surgical, General Use

Devices cleared under the same product code (FZS) and FDA review panel - the closest regulatory comparables to K871925.
CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER
K891888 · Zinnanti Surgical Instruments, Inc. · Apr 1989
ADENOID CURETTE
K890366 · Kinetic Medical Products · Feb 1989
MICRODISCECTOMY CURETTE SET
K875292 · T. Korossurgical Instruments Corp. · Jan 1988
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU
K842701 · Downs Surgical , Ltd. · Aug 1984
PMN VOLZ CURETTES
K831367 · 3M Company · May 1983
ANSPACH MENISECTOMY KNIFE
K803178 · The Anspach Effort, Inc. · Feb 1981