Cleared Traditional

K874959 - VASCULAR CLAMP

K874959 is an FDA 510(k) clearance for VASCULAR CLAMP, manufactured by Solway, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HXD cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K874959 · Solway, Inc. · General & Plastic Surgery device
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Dec 1987
Decision
28d
Days
Class 1
Risk

K874959 is an FDA 510(k) clearance for the VASCULAR CLAMP. Classified as Clamp (product code HXD), Class I - General Controls.

Submitted by Solway, Inc. (Hollywood, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Solway, Inc. devices

FDA 510(k) Submission Details - K874959

510(k) Number K874959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date December 30, 1987
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

HXD Device Classification - Class 1, General Controls

Product Code HXD Clamp
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - HXD Clamp

All 9
Devices cleared under the same product code (HXD) and FDA review panel - the closest regulatory comparables to K874959.
INTESTINAL CRUSHING CLAMP
K890371 · Kinetic Medical Products · Feb 1989
INTESTINAL CLAMP
K890372 · Kinetic Medical Products · Feb 1989
PARAMETRIUM CLAMP
K890381 · Kinetic Medical Products · Feb 1989
C CLAMP
K872386 · Med-Tool, Inc. · Jul 1987
SUCTION-OFF
K863653 · B&B Medical Technologies, Inc. · Oct 1986
CANNULA CLAMP
K853538 · Cp Medical · Sep 1985