Cleared Traditional

K132300 - EPIX ELECTROSURGICAL PROBE SPATULA TIP

K132300 is the FDA 510(k) clearance for EPIX ELECTROSURGICAL PROBE SPATULA TIP by Applied Medical Resources Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K132300 · Applied Medical Resources Corp. · General & Plastic Surgery device
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Jan 2014
Decision
184d
Days
Class 2
Risk

K132300 is an FDA 510(k) clearance for the EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on January 24, 2014 after a review of 184 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 Applied Medical Resources Corp. devices

Submission Details

510(k) Number K132300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2013
Decision Date January 24, 2014
Days to Decision 184 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
69d slower than avg
Panel avg: 115d · This submission: 184d
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 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K132300.
THUNDERBEAT
K132703 · Olympus Medical Systems Corp. · May 2014
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K140839 · Aesculap, Inc. · Apr 2014
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K140495 · Boston Scientific Corp · Apr 2014
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
K133726 · Megadyne Medical Products, Inc. · Jan 2014
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
K133167 · Intuitive Surgical, Inc. · Jan 2014
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K133180 · Erbe USA, Inc. · Dec 2013