Cleared Traditional

K002717 - STERILE PISTON SYRINGE

K002717 is an FDA 510(k) clearance for STERILE PISTON SYRINGE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K002717 · Abbott Laboratories · General Hospital
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Jan 2001
Decision
130d
Days
Class 2
Risk

K002717 is an FDA 510(k) clearance for the STERILE PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K002717

510(k) Number K002717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2000
Decision Date January 08, 2001
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K002717.
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · Orthovita, Inc. · Sep 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl. · Apr 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp. · Feb 2001
INJECTRITE-C15 AND INJECTRITE-C30
K002127 · Sterling Medivations, Inc. · Dec 2000
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000