Cleared Traditional

K881144 - YESNG PATIENT PLATE #80226

K881144 is the FDA 510(k) clearance for YESNG PATIENT PLATE #80226 by Ferguson Medical. It is a Class 2 General & Plastic Surgery device (product code JOS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K881144 · Ferguson Medical · General & Plastic Surgery device
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Apr 1988
Decision
22d
Days
Class 2
Risk

K881144 is an FDA 510(k) clearance for the YESNG PATIENT PLATE #80226. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on April 8, 1988 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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: 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 Ferguson Medical devices

Submission Details

510(k) Number K881144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1988
Decision Date April 08, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JOS Electrode, Electrosurgical

All 18
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K881144.
ELECTRODE EXTENDER
K905060 · Megadyne Medical Products, Inc. · Apr 1991
ELECTRODE, ELECTROSURGERY
K903302 · Megadyne Medical Products, Inc. · Oct 1990
MICRO CAUTERY NEEDLES
K891400 · Zinnanti Surgical Instruments, Inc. · Apr 1989
MONOPOLAR CAUTERY BLADE TIP #TM-1701
K873653 · Arthropedics, Inc. · Dec 1987
MONOPOLAR CAUTERY CONICAL TIP #TM-1702
K873654 · Arthropedics, Inc. · Dec 1987
MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
K873655 · Arthropedics, Inc. · Dec 1987