Cleared Traditional

AUTO SUTURE CHEMOSITE TUNNELER (K961856) - FDA 510(k) Clearance

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

K961856 · United States Surgical, A Division of Tyco Healthc · General Hospital
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Jul 1996
Decision
65d
Days
Class 2
Risk

K961856 is an FDA 510(k) clearance for the AUTO SUTURE CHEMOSITE TUNNELER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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

Submission Details

510(k) Number K961856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date July 18, 1996
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 86
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K961856.
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K971085 · B.Braun Medical, Inc. · Jun 1997
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 1995
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
K893126 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988