Cleared Traditional

K920819 - ABDOVAC (TM)

K920819 is an FDA 510(k) clearance for ABDOVAC (TM), manufactured by Astra Meditec AB. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K920819 · Astra Meditec AB · General & Plastic Surgery device
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Mar 1993
Decision
394d
Days
Class 1
Risk

K920819 is an FDA 510(k) clearance for the ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Astra Meditec AB (Sweden, SE). The FDA issued a Cleared decision on March 24, 1993 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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. Elevated predicate reliance profile. 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 Astra Meditec AB devices

FDA 510(k) Submission Details - K920819

510(k) Number K920819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 24, 1992
Decision Date March 24, 1993
Days to Decision 394 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 115d · This submission: 394d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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