Cleared Traditional

K955606 - PISTON SYRINGE

K955606 is an FDA 510(k) clearance for PISTON SYRINGE, manufactured by Medical Surgical Intl.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K955606 · Medical Surgical Intl. · General Hospital
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Jul 1996
Decision
230d
Days
Class 2
Risk

K955606 is an FDA 510(k) clearance for the PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medical Surgical Intl. (Scottsdale, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 230 days - an extended review cycle.

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 Medical Surgical Intl. devices

FDA 510(k) Submission Details - K955606

510(k) Number K955606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date July 25, 1996
Days to Decision 230 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
101d slower than avg
Panel avg: 129d · This submission: 230d
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 416
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K955606.
GLASS SYRINGE
K962042 · Ispg, Inc. · Oct 1996
GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10
K962329 · Global Medical Prods, Inc. · Sep 1996
SHIFA STERILE DISPOSABLE SYRINGES
K962614 · International Regulatory Consultants · Sep 1996
CONTROL SYRINGE
K960882 · Louisville Laboratories, Inc. · Jul 1996
BRANNON PEDI PORTSYRINGE
K960047 · James K. Brannon · May 1996
BRANNON PORTSYRINGE
K960049 · James K. Brannon · May 1996