Cleared Traditional

K895516 - CAVITY DRAINAGE CATHETERIZATION SET

K895516 is an FDA 510(k) clearance for CAVITY DRAINAGE CATHETERIZATION SET, manufactured by Arrow Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K895516 · Arrow Intl., Inc. · General & Plastic Surgery device
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Dec 1989
Decision
106d
Days
Class 1
Risk

K895516 is an FDA 510(k) clearance for the CAVITY DRAINAGE CATHETERIZATION SET, CS-01600. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K895516

510(k) Number K895516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date December 27, 1989
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
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 33
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K895516.
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · Baxter Healthcare Corp · Mar 1991
PVC ROUND WOUND DRAINS
K905422 · Axiom Medical, Inc. · Feb 1991
DISPOSABLE FLUID COLLECTION BAG
K904133 · Axiom Medical, Inc. · Oct 1990
THORACIC CATHETERS
K883474 · Westmark, Sterile Packing Systems, Inc. (Sps) · Sep 1988
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · American Pharmaseal Div. Ahsc · Mar 1987
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985