Cleared Traditional

K962544 - MICRO DIAMOND-POINT DISSECTION NEEDLES

K962544 is an FDA 510(k) clearance for MICRO DIAMOND-POINT DISSECTION NEEDLES, manufactured by Dsp Worldwide. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K962544 · Dsp Worldwide · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
84d
Days
Class 2
Risk

K962544 is an FDA 510(k) clearance for the MICRO DIAMOND-POINT DISSECTION NEEDLES. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Dsp Worldwide (North Attleboro, US). The FDA issued a Cleared decision on September 20, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Dsp Worldwide devices

FDA 510(k) Submission Details - K962544

510(k) Number K962544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date September 20, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOS Device Classification - Class 2, Special Controls

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JOS Electrode, Electrosurgical

All 22
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K962544.
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · Aaron Medical Industries · Jun 1998
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
K973554 · Valley Forge Scientific Corp. · Dec 1997
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · Aaron Medical Industries · May 1997
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950455 · Aaron Medical Industries · May 1995
ELECTRODES
K944992 · Linvatec Corp. · Apr 1995
MILES SODIUM METHOD
K923037 · Heraeus Kulzer, Inc. · Sep 1992