Cleared Traditional

K945002 - 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE

K945002 · Certified Safety Mfg., Inc. · General & Plastic Surgery device
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Mar 1995
Decision
160d
Days
-
Risk

K945002 is an FDA 510(k) clearance for the 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K945002

510(k) Number K945002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date March 22, 1995
Days to Decision 160 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
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 192
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K945002.
LOCKETT MEDICAL CORP. GAUZE
K950404 · Lockett Medical Corp. · Apr 1995
GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)
K950462 · Spring Intl., Inc. · Apr 1995
LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
K951418 · Lorons International Corp. · Apr 1995
2, 3 & 4 BANDADGE COMPRESS
K945004 · Certified Safety Mfg., Inc. · Mar 1995
DUTEX GAUZE BANDAGE
K946326 · Dumex Medical Surgical Products, Ltd. · Jan 1995
LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS
K945960 · Lorons International Corp. · Jan 1995
K945002 · 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
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