Cleared Traditional

K971588 - EVI SUTURED-CLIP APPLIER

K971588 is an FDA 510(k) clearance for EVI SUTURED-CLIP APPLIER, manufactured by Elective Vascular Intervention Inc. (Evi). The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K971588 · Elective Vascular Intervention Inc. (Evi) · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K971588

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
Combination Product No
PCCP Authorized No
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.

FZP Device Classification - Class 2, Special Controls

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 123
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K971588.
INFLUENCE CLIP SYSTEM
K981631 · Influence, Inc. · Jul 1998
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K981239 · Deroyal Surgical · May 1998
DUOCLIPPER TITANIUM CLIPS
K973652 · Scion International, Inc. · Mar 1998
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
APPLIED MEDICAL CLIP APPLIER
K964470 · Applied Medical Resources · Jan 1997