Cleared Traditional

K984438 - MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE

K984438 is an FDA 510(k) clearance for MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC*..., manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K984438 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
24d
Days
Class 2
Risk

K984438 is an FDA 510(k) clearance for the MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on January 7, 1999 after a review of 24 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K984438

510(k) Number K984438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1998
Decision Date January 07, 1999
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 144
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K984438.
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
K993157 · Weck Closure Systems · Dec 1999
IMPLANTABLE CLIP FOR GENERAL SURGERY
K993135 · Applied Medical Resources · Dec 1999
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
K991002 · V. Mueller Neuro/Spine · Jun 1999
HEM-O-LOK MODEL NUMBERS 523900, 523970
K982941 · Weck Closure Systems · Nov 1998
HEM-O-LOCK, MODEL 523935
K982944 · Weck Closure Systems · Nov 1998
TITANIUM HEMOSTATIC CLIP
K981645 · Vitalitec Int'L., Inc. · Oct 1998