Cleared Traditional

K955776 - ACU-LAB

K955776 · Glederer & Co., Inc. · General & Plastic Surgery device
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Jun 1996
Decision
168d
Days
-
Risk

K955776 is an FDA 510(k) clearance for the ACU-LAB.

Submitted by Glederer & Co., Inc. (Paterson, US). The FDA issued a Cleared decision on June 5, 1996 after a review of 168 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.

View all Glederer & Co., Inc. devices

FDA 510(k) Submission Details - K955776

510(k) Number K955776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1995
Decision Date June 05, 1996
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 39
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K955776.
PIV SYSTEM
K981032 · Medical Solutions, Inc. · Sep 1998
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ACU-HALT
K955661 · Glederer & Co., Inc. · Dec 1996
NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
K925588 · North American Sterilization & Packaging Co. · Dec 1993
NORTEC STERILE WATER FOR DEVICE IRRIGATION
K925593 · North American Sterilization & Packaging Co. · Dec 1993
OLYMPIC WARMETTE
K911955 · Olympic Medical Corp. · Jul 1991