Cleared Traditional

K010265 - BAYLIS MEDICAL RF PERFORATION PROBE

K010265 is the FDA 510(k) clearance for BAYLIS MEDICAL RF PERFORATION PROBE by Baylis Medical Co., Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K010265 · Baylis Medical Co., Inc. · General & Plastic Surgery device
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Apr 2001
Decision
73d
Days
Class 2
Risk

K010265 is an FDA 510(k) clearance for the BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on April 9, 2001 after a review of 73 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 Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K010265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2001
Decision Date April 09, 2001
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
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 1173
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K010265.
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · Boston Scientific Corp · Apr 2001
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K002000 · Richard Wolf Medical Instruments Corp. · Apr 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
K002981 · Ethicon Endo-Surgery, Inc. · Apr 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
K010010 · Valleylab, Inc. · Apr 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K010013 · Valleylab, Inc. · Mar 2001
ENDIUS BIPOLAR SHEATH
K003897 · Endius, Inc. · Mar 2001