Cleared Traditional

EVI SUTURED-CLIP APPLIER (K971588) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971588 · Elective Vascular Intervention Inc. (Evi) · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
176d
Days
Class 2
Risk

K971588 is an FDA 510(k) clearance for the EVI SUTURED-CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Elective Vascular Intervention Inc. (Evi) (Walnut Creek, US). The FDA issued a Cleared decision on October 24, 1997 after a review of 176 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Elective Vascular Intervention Inc. (Evi) devices

Submission Details

510(k) Number K971588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date October 24, 1997
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 57
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K971588.
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories · Jun 2005
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc · Jul 2000
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · United States Surgical, A Division of Tyco Healthc · Jan 1999
IMPLANTABLE CLIP
K970793 · United States Surgical, A Division of Tyco Healthc · Jul 1997
AUTO SUTURE* ILM** KIT
K971201 · United States Surgical, A Division of Tyco Healthc · Jun 1997
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · United States Surgical, A Division of Tyco Healthc · Sep 1996