Cleared Traditional

K960955 - JACKSON-PRATT GOLD WOUND DRAINS WITH DU...

K960955 is the FDA 510(k) clearance for JACKSON-PRATT GOLD WOUND DRAINS WITH DU... by Baxter Healthcare Corp. It is a Class 1 General & Plastic Surgery device (product code GBX) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K960955 · Baxter Healthcare Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
72d
Days
Class 1
Risk

K960955 is an FDA 510(k) clearance for the JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on May 22, 1996 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K960955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date May 22, 1996
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 23
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K960955.
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · Allegiance Healthcare Corp. · Dec 1997
CLOSED FLUID COLLECTION SYSTEM
K961147 · B.Braun Medical, Inc. · May 1996
HYDROLOGY 5000
K955339 · Northgate Technologies, Inc. · Mar 1996
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243 · Deknatel, Inc. · Jul 1994
STORZ N5941 SERIES MEDICAL GRADE TUBING
K940352 · Storz Instrument Co. · Apr 1994
ERCP CATHETER, HYDROPHILIC COATED
K932205 · Wilson-Cook Medical, Inc. · Jan 1994