Cleared Traditional

K955166 - PENEVAC SI.

K955166 is an FDA 510(k) clearance for PENEVAC SI., manufactured by I.C Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K955166 · I.C Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
150d
Days
Class 2
Risk

K955166 is an FDA 510(k) clearance for the PENEVAC SI.. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by I.C Medical, Inc. (Glendale, US). The FDA issued a Cleared decision on April 11, 1996 after a review of 150 days - an extended review 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: 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 - K955166

510(k) Number K955166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date April 11, 1996
Days to Decision 150 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2201
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K955166.
ARCO-MBC, ARCO MC
K954171 · Holl Meditronics, Inc. · Apr 1996
ZOMED 30F ELECTROSURGICAL PROBE
K960694 · Zomed Intl. · Apr 1996
MODEL 200C ELECTROSURGICAL PROBE
K960695 · Zomed Intl. · Apr 1996
PENEVAC ABC HANDPIECE
K955020 · I.C Medical, Inc. · Apr 1996
RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000
K955144 · Radiotherapeutics Corp. · Apr 1996
SUCTION CAUTERY PROBE
K955352 · Mectra Labs, Inc. · Apr 1996
K955166 · PENEVAC SI.
Download PDF FDA Summary I.C Medical, Inc.