Cleared Traditional

K960456 - DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY

K960456 is an FDA 510(k) clearance for DENVER PARACENTESIS NEEDLE(60-1200) DEN..., manufactured by Denver Biomaterials, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K960456 · Denver Biomaterials, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
62d
Days
Class 1
Risk

K960456 is an FDA 510(k) clearance for the DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE .... Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Denver Biomaterials, Inc. (Evergreen, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 62 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 Denver Biomaterials, Inc. devices

FDA 510(k) Submission Details - K960456

510(k) Number K960456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1996
Decision Date April 01, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, 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 - KDD Kit, Surgical Instrument, Disposable

All 30
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K960456.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
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SUTURE SET OR LACERATION TRAYS (PACKS)
K932219 · Associated Medical Products Co. · Jul 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923176 · Ulti-Med Intl., Inc. · Jun 1993
DEXIDE LAPAROSCOPIC KITS
K924117 · Dexide, Inc. · Mar 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K920989 · Ulti-Med Intl., Inc. · Oct 1992