Cleared Traditional

K924524 - FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE ...

K924524 is an FDA 510(k) clearance for FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE ..., manufactured by Valleylab, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K924524 · Valleylab, Inc. · General & Plastic Surgery device
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Apr 1993
Decision
209d
Days
Class 2
Risk

K924524 is an FDA 510(k) clearance for the FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE EXTENDER. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on April 5, 1993 after a review of 209 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.

View all Valleylab, Inc. devices

FDA 510(k) Submission Details - K924524

510(k) Number K924524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1992
Decision Date April 05, 1993
Days to Decision 209 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
94d slower than avg
Panel avg: 115d · This submission: 209d
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 1192
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K924524.
VALLEYLAB CURRENT MONITOR, E3350 & E3351
K926415 · Valleylab, Inc. · Apr 1993
EXCALIBUR ELECTROSURGICAL UNIT
K924960 · Aspen Laboratories, Inc. · Apr 1993
GRASPERS & SCISSORS (MINIMAL ACCESS SURG INSTR)
K924469 · Conmedcorp · Apr 1993
NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)
K925130 · Laserscope · Mar 1993
FOOT CONTROL PENCIL
K926306 · Megadyne Medical Products, Inc. · Feb 1993
FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)
K924918 · Valleylab, Inc. · Jan 1993