Cleared Traditional

K100754 - GRAFT DELIVERY SYSTEM MODEL SA-6115

K100754 is an FDA 510(k) clearance for GRAFT DELIVERY SYSTEM MODEL SA-6115, manufactured by Micromedics, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K100754 · Micromedics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
84d
Days
Class 2
Risk

K100754 is an FDA 510(k) clearance for the GRAFT DELIVERY SYSTEM MODEL SA-6115. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 9, 2010 after a review of 84 days - a notably fast clearance 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: 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 Micromedics, Inc. devices

FDA 510(k) Submission Details - K100754

510(k) Number K100754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2010
Decision Date June 09, 2010
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 481
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