Cleared Traditional

K950065 - CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS

K950065 · Conmedcorp · General & Plastic Surgery device
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Mar 1995
Decision
74d
Days
-
Risk

K950065 is an FDA 510(k) clearance for the CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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FDA 510(k) Submission Details - K950065

510(k) Number K950065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1995
Decision Date March 24, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 60
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K950065.
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CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
K946338 · Certified Safety Mfg., Inc. · Mar 1995
CUTIPLAST STERIL
K943363 · Beiersdorf, Inc. · Mar 1995
CUSH ISLAND DRESSING
K943424 · Cush Medical Products · Oct 1994
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · The Kendal Co. · Jul 1994