Cleared Special

K070814 - MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP

K070814 is an FDA 510(k) clearance for MODIFICATION TO CONFLUENT SURGICAL MICR..., manufactured by Confluent Surgical,Inc. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 65-day FDA review.

K070814 · Confluent Surgical,Inc · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
65d
Days
Class 2
Risk

K070814 is an FDA 510(k) clearance for the MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Confluent Surgical,Inc (Waltham, US). The FDA issued a Cleared decision on May 30, 2007 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 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070814

510(k) Number K070814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 30, 2007
Days to Decision 65 days
Submission Type Special
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
Modification to existing cleared device.

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 638
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070814.
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K070264 · Terumo Europe N.V. · May 2007
EVICEL APPLICATION DEVICE
K070575 · Omrix Biopharmaceuticals , Ltd. · May 2007
TEXIUM SYRINGE
K071108 · Cardinal Health, Alaris Products · May 2007
K070814 · MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
Download PDF FDA Summary Confluent Surgical,Inc