Cleared Traditional

K963338 - UNIMED SUCTION-IRRIGATION ELECTRODE AND...

K963338 is the FDA 510(k) clearance for UNIMED SUCTION-IRRIGATION ELECTRODE AND... by Unimed Surgical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K963338 · Unimed Surgical Products, Inc. · General & Plastic Surgery device
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Oct 1996
Decision
59d
Days
Class 2
Risk

K963338 is an FDA 510(k) clearance for the UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Unimed Surgical Products, Inc. (Largo, US). The FDA issued a Cleared decision on October 21, 1996 after a review of 59 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 Unimed Surgical Products, Inc. devices

Submission Details

510(k) Number K963338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1996
Decision Date October 21, 1996
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 893
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K963338.
VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES
K964175 · Valleylab, Inc. · Dec 1996
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
K963783 · Ethicon, Inc. · Nov 1996
E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
K962690 · Valleylab, Inc. · Nov 1996
DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
K961647 · Deroyal Industries, Inc. · Oct 1996
ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)
K963123 · Arthrocare Corp. · Oct 1996
MIRROR FINISH BIPOLAR FORCEPS
K963499 · Johnson & Johnson Professionals, Inc. · Oct 1996