Cleared Traditional

K841009 - SURGICAL RETRACTORS-VARIOUS

K841009 is the FDA 510(k) clearance for SURGICAL RETRACTORS-VARIOUS by Premier Dental Products Co.. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K841009 · Premier Dental Products Co. · General & Plastic Surgery device
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May 1984
Decision
53d
Days
Class 1
Risk

K841009 is an FDA 510(k) clearance for the SURGICAL RETRACTORS-VARIOUS. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 53 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K841009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date May 01, 1984
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
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 - GAD Retractor

All 18
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K841009.
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
21-450 GELPI RETRACTOR
K851776 · Artiberia · Jun 1985
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983
ETHICON RETRACTION TAPE
K801699 · Ethicon, Inc. · Sep 1980