Cleared Traditional

K963901 - ELECTROSURGICAL PROBE

K963901 is an FDA 510(k) clearance for ELECTROSURGICAL PROBE, manufactured by Smith & Nephew Endoscopy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K963901 · Smith & Nephew Endoscopy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
38d
Days
Class 2
Risk

K963901 is an FDA 510(k) clearance for the ELECTROSURGICAL PROBE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Smith & Nephew Endoscopy, Inc. (Andover, US). The FDA issued a Cleared decision on November 4, 1996 after a review of 38 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 Smith & Nephew Endoscopy, Inc. devices

FDA 510(k) Submission Details - K963901

510(k) Number K963901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1996
Decision Date November 04, 1996
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 1748
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K963901.
HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE
K961334 · Heartport, Inc. · Nov 1996
ELECTROSURGICAL PROBES & DEVICES
K962593 · Ximed/Prosure/Injectx · Nov 1996
E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
K962690 · Valleylab, Inc. · Nov 1996
SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
K963772 · Somnus Medical Technologies, Inc. · Oct 1996
UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
K963338 · Unimed Surgical Products, Inc. · Oct 1996
VIDAMED RF GENERATOR DATA RECORDER
K963180 · Vidamed, Inc. · Oct 1996