Cleared Traditional

K903649 - BRADLEY TENACULUM HOLDER

K903649 is the FDA 510(k) clearance for BRADLEY TENACULUM HOLDER by Marlo Surgical Technology. It is a Class 1 General & Plastic Surgery device (product code KDC) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K903649 · Marlo Surgical Technology · General & Plastic Surgery device
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Nov 1990
Decision
81d
Days
Class 1
Risk

K903649 is an FDA 510(k) clearance for the BRADLEY TENACULUM HOLDER. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on November 2, 1990 after a review of 81 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 Marlo Surgical Technology devices

Submission Details

510(k) Number K903649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date November 02, 1990
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDC Instrument, Surgical, Disposable
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 - KDC Instrument, Surgical, Disposable

All 17
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K903649.
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
K936226 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1994
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
RICHARD-ALLAN VESSEL LOOPS
K900566 · Richard-Allan Medical Ind., Inc. · May 1990
C-LOOPS
K830800 · Concept, Inc. · Oct 1983
DISPOSABLE SCALPELS
K831798 · I M, Inc. · Jul 1983
DEVO'N LOOPS
K830248 · Devon Industries, Inc. · Mar 1983