Cleared Special

CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 (K010210) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010210 · Curon Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
29d
Days
Class 2
Risk

K010210 is an FDA 510(k) clearance for the CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Curon Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Curon Medical, Inc. devices

Submission Details

510(k) Number K010210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2001
Decision Date February 21, 2001
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 570
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K010210.
BIPOLAR IRRIGATION FORCEPS
K012986 · Aesculap, Inc. · Oct 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · Boston Scientific Corp · Apr 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
K010444 · C.R. Bard, Inc. · Feb 2001
CLEARGLIDE PRECISION BIPOLAR DEVICE
K003587 · Ethicon, Inc. · Dec 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · Aesculap, Inc. · May 2000
DYONICS ELECTROBLADE
K994365 · Smith & Nephew, Inc. · Mar 2000