Cleared Traditional

K902828 - SUTURE REMOVAL TRAY

K902828 is an FDA 510(k) clearance for SUTURE REMOVAL TRAY, manufactured by Orion Life Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code LRW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K902828 · Orion Life Systems, Inc. · General & Plastic Surgery device
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Aug 1990
Decision
41d
Days
Class 1
Risk

K902828 is an FDA 510(k) clearance for the SUTURE REMOVAL TRAY. Classified as Scissors, General, Surgical (product code LRW), Class I - General Controls.

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on August 8, 1990 after a review of 41 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 Orion Life Systems, Inc. devices

FDA 510(k) Submission Details - K902828

510(k) Number K902828 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 28, 1990
Decision Date August 08, 1990
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

LRW Device Classification - Class 1, General Controls

Product Code LRW Scissors, General, Surgical
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 - LRW Scissors, General, Surgical

All 12
Devices cleared under the same product code (LRW) and FDA review panel - the closest regulatory comparables to K902828.
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM
K911158 · Northgate Technologies, Inc. · Mar 1991
GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM
K900950 · Solos Endoscopy, Inc. · Apr 1990
GS-2100 HOOK SUTURE SCISSOR, 5MM
K900957 · Solos Endoscopy, Inc. · Apr 1990
SCISSORS, VARIOUS TYPES
K891886 · Zinnanti Surgical Instruments, Inc. · Apr 1989
OLIVECORONA SCISSORS
K891889 · Zinnanti Surgical Instruments, Inc. · Apr 1989
RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS
K891200 · Zinnanti Surgical Instruments, Inc. · Apr 1989