Cleared Traditional

K902000 - KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD

K902000 is an FDA 510(k) clearance for KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/..., manufactured by Kevtek Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K902000 · Kevtek Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
111d
Days
Class 1
Risk

K902000 is an FDA 510(k) clearance for the KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD. Classified as Curette, Surgical, General Use (product code FZS), Class I - General Controls.

Submitted by Kevtek Medical Products, Inc. (Houston, US). The FDA issued a Cleared decision on August 21, 1990 after a review of 111 days - within the typical 510(k) review window.

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: 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 Kevtek Medical Products, Inc. devices

FDA 510(k) Submission Details - K902000

510(k) Number K902000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date August 21, 1990
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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

All 7
Devices cleared under the same product code (FZS) and FDA review panel - the closest regulatory comparables to K902000.
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
STRAIGHT CUP CURRETTE, 1.7MM
K871925 · Arthropedics, Inc. · Jun 1987
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU
K842701 · Downs Surgical , Ltd. · Aug 1984
PMN VOLZ CURETTES
K831367 · 3M Company · May 1983