Cleared Traditional

K960955 - JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING

K960955 is an FDA 510(k) clearance for JACKSON-PRATT GOLD WOUND DRAINS WITH DU..., manufactured by Baxter Healthcare Corp. The device is a Class 1 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K960955

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.

GBX Device Classification - Class 1, General Controls

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 47
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K960955.
FLAT CLOSED WOUND DRAIN WITH TROCAR
K965146 · Axiom Medical, Inc. · Mar 1997
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
K961295 · Sil-Med Corp. · Jun 1996
CLOSED FLUID COLLECTION SYSTEM
K961147 · B.Braun Medical, Inc. · May 1996
HYDROLOGY 5000
K955339 · Northgate Technologies, Inc. · Mar 1996
NEO-PNEUMOCATH
K955474 · Intra Special Catheters GmbH · Feb 1996
OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
K955505 · Navarre Biomedical , Ltd. · Feb 1996