Cleared Traditional

K870704 - CLOSED PARACENTESIS SYSTEM W/BOASBERG C...

K870704 is an FDA 510(k) clearance for CLOSED PARACENTESIS SYSTEM W/BOASBERG C..., manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K870704 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
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Mar 1987
Decision
35d
Days
Class 1
Risk

K870704 is an FDA 510(k) clearance for the CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 35 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K870704

510(k) Number K870704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received February 20, 1987
Decision Date March 27, 1987
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 38
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K870704.
DISPOSABLE FLUID COLLECTION BAG
K904133 · Axiom Medical, Inc. · Oct 1990
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516 · Arrow Intl., Inc. · Dec 1989
THORACIC CATHETERS
K883474 · Westmark, Sterile Packing Systems, Inc. (Sps) · Sep 1988
MICROTEK IRRIGATION SYSTEM
K844061 · Microtek Medical, Inc. · May 1985
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984