Cleared Traditional

K981631 - INFLUENCE CLIP SYSTEM

K981631 is an FDA 510(k) clearance for INFLUENCE CLIP SYSTEM, manufactured by Influence, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K981631 · Influence, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
82d
Days
Class 2
Risk

K981631 is an FDA 510(k) clearance for the INFLUENCE CLIP SYSTEM. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Influence, Inc. (Washington, US). The FDA issued a Cleared decision on July 28, 1998 after a review of 82 days - a notably fast clearance 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: 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 Influence, Inc. devices

FDA 510(k) Submission Details - K981631

510(k) Number K981631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1998
Decision Date July 28, 1998
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 104
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K981631.
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc · Jul 2000
IMPLANTABLE CLIP FOR GENERAL SURGERY
K993135 · Applied Medical Resources · Dec 1999
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
APPLIED MEDICAL CLIP APPLIER
K964470 · Applied Medical Resources · Jan 1997