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.

View all Medi-Flex Hospital Products, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 194
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K952007.
RECLOSABLE WOUND COVER
K954621 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990