Cleared Traditional

K962755 - STRYKER ENCORE STERILIZER

K962755 is an FDA 510(k) clearance for STRYKER ENCORE STERILIZER, manufactured by Stryker Corp.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K962755 · Stryker Corp. · General Hospital
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Mar 1997
Decision
231d
Days
Class 2
Risk

K962755 is an FDA 510(k) clearance for the STRYKER ENCORE STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 231 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corp. devices

FDA 510(k) Submission Details - K962755

510(k) Number K962755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1996
Decision Date March 04, 1997
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 129d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 125
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K962755.
CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)
K970907 · Getinge/Castle, Inc. · Nov 1997
TUTTNAUER TABLE-TOP AUTOCLAVE
K973550 · Tuttnauer U.S.A Co, Ltd. · Oct 1997
STERRADD STERILIZATION SYSTEM
K954142 · Advanced Sterilization Products · Jun 1997
DELTA
K945117 · Pelton & Crane Co. · Feb 1997
STERILEMAX
K953938 · Barnstead/Thermolyne Corp. · Jan 1997
STAT IM 5000 CASSETTE AUTOCLAVE
K962179 · Scican · Jan 1997