Cleared Traditional

K952007 - ADHEROL SEPP APPLICATOR

K952007 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery device
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Jun 1995
Decision
41d
Days
-
Risk

K952007 is an FDA 510(k) clearance for the ADHEROL SEPP APPLICATOR. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on June 8, 1995 after a review of 41 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.

FDA 510(k) Submission Details - K952007

510(k) Number K952007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date June 08, 1995
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 653
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K952007.
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
EX-111 WOUND DRESSING
K952907 · Variseal Manufacturing Corp. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
DUMEX WET DRESSINGS
K950132 · Dumex Medical Surgical Products, Ltd. · Mar 1995
KIT PAK WET SALINE DRESSING
K942959 · Kit Pak, Inc. · Feb 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
K952007 · ADHEROL SEPP APPLICATOR
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