Cleared Traditional

K881036 - HEMO SUC NUMBER HS100-HS205

K881036 is an FDA 510(k) clearance for HEMO SUC NUMBER HS100-HS205, manufactured by Instrumental Medico Croquevielle S.A.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K881036 · Instrumental Medico Croquevielle S.A. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1988
Decision
102d
Days
Class 1
Risk

K881036 is an FDA 510(k) clearance for the HEMO SUC NUMBER HS100-HS205. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Instrumental Medico Croquevielle S.A. (Santiago, Chile, CL). The FDA issued a Cleared decision on June 20, 1988 after a review of 102 days - within the typical 510(k) review window.

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. 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 Instrumental Medico Croquevielle S.A. devices

FDA 510(k) Submission Details - K881036

510(k) Number K881036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date June 20, 1988
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
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

All 52
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