Cleared Traditional

K943991 - O-R-EZ TIP CLEANER

K943991 is an FDA 510(k) clearance for O-R-EZ TIP CLEANER, manufactured by O-R-Ez, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K943991 · O-R-Ez, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
16d
Days
Class 2
Risk

K943991 is an FDA 510(k) clearance for the O-R-EZ TIP CLEANER. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by O-R-Ez, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 16 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 O-R-Ez, Inc. devices

FDA 510(k) Submission Details - K943991

510(k) Number K943991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date September 01, 1994
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
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 1974
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K943991.
FORCE GSU-SLPM SYSTEM
K943865 · Valleylab, Inc. · Sep 1994
FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22
K942579 · Valleylab, Inc. · Sep 1994
ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE
K943542 · Conmedcorp · Sep 1994
FLOWGUN ELECTROCAUTERY PROBES
K941337 · O.R. Concepts, Inc. · Aug 1994
454A ELECTROSURGICAL ANALYZER
K942627 · Hogan & Hartson · Aug 1994
BIOPLAR FORCEPS
K943231 · Cook Urological, Inc. · Jul 1994