Cleared Traditional

K822155 - ETHICON TEMPORARY CARDIAC PACING WIRE

K822155 is an FDA 510(k) clearance for ETHICON TEMPORARY CARDIAC PACING WIRE, manufactured by Ethicon, Inc.. The device is a Class 3 Orthopedic device with product code LOF cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K822155 · Ethicon, Inc. · Orthopedic device
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Aug 1982
Decision
32d
Days
Class 3
Risk

K822155 is an FDA 510(k) clearance for the ETHICON TEMPORARY CARDIAC PACING WIRE. Classified as Stimulator, Bone Growth, Non-invasive (product code LOF), Class III - Premarket Approval.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1982 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

FDA 510(k) Submission Details - K822155

510(k) Number K822155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1982
Decision Date August 24, 1982
Days to Decision 32 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

LOF Device Classification - Class 3, Premarket Approval

Product Code LOF Stimulator, Bone Growth, Non-invasive
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.