Cleared Traditional

K890229 - SURGICAL NEEDLE HOLDERS

K890229 is an FDA 510(k) clearance for SURGICAL NEEDLE HOLDERS, manufactured by Kinetic Medical Products. The device is a Class 1 General & Plastic Surgery device with product code GDF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K890229 · Kinetic Medical Products · General & Plastic Surgery device
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Jan 1989
Decision
9d
Days
Class 1
Risk

K890229 is an FDA 510(k) clearance for the SURGICAL NEEDLE HOLDERS. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 9 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890229

510(k) Number K890229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

GDF Device Classification - Class 1, General Controls

Product Code GDF Guide, Needle, 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 - GDF Guide, Needle, Surgical

All 14
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K890229.
ACCUPLACE (TM)
K904172 · Dlp, Inc. · Nov 1990
MICROSURGICAL NEEDLE HOLDERS
K890211 · Kinetic Medical Products · Jan 1989
SURGICAL NEEDLE GUIDE
K890228 · Kinetic Medical Products · Jan 1989
WILLIAMS ACS MARKER NEEDLE
K882036 · Buckman Co., Inc. · Jul 1988
BIOPSY ADAPTER #H4221BG
K864551 · General Electric Co. · Dec 1986
PERCU GUIDE I (LOOP TYPE)
K863090 · E-Z-Em, Inc. · Aug 1986