Cleared Traditional

K934088 - AUTO SUTURE SHARPS CONTAINER

K934088 is an FDA 510(k) clearance for AUTO SUTURE SHARPS CONTAINER, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K934088 · United States Surgical, A Division of Tyco Healthc · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
163d
Days
Class 2
Risk

K934088 is an FDA 510(k) clearance for the AUTO SUTURE SHARPS CONTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 163 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K934088

510(k) Number K934088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1993
Decision Date February 03, 1994
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 495
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K934088.
MONOJECT VERTICAL ENTRY SHARPS CONTAINER
K934404 · Sherwood Medical Co. · Feb 1994
SHARPSAFE CAT. NO. 4127
K935628 · Smiths Industries Medical Systems, Inc. · Feb 1994
NON-CORNING (HUBER) NEEDLE
K936029 · Therex Corp. · Feb 1994
WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
K935505 · Kawasumi Laboratories Co., Ltd. · Feb 1994
MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
K935506 · Kawasumi Laboratories Co., Ltd. · Feb 1994
BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE
K931019 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1993