Cleared Special

K013348 - MODIFICATION TO: ERBE APC CONNECTOR HOS...

K013348 is an FDA 510(k) clearance for MODIFICATION TO: ERBE APC CONNECTOR HOS..., manufactured by Erbe USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 17-day FDA review.

K013348 · Erbe USA, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2001
Decision
17d
Days
Class 2
Risk

K013348 is an FDA 510(k) clearance for the MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on October 26, 2001 after a review of 17 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 Erbe USA, Inc. devices

FDA 510(k) Submission Details - K013348

510(k) Number K013348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date October 26, 2001
Days to Decision 17 days
Submission Type Special
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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 K013348.
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · Sterilmed, Inc. · Nov 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
K012700 · Vanguard Medical Concepts, Inc. · Nov 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K012695 · Vanguard Medical Concepts, Inc. · Oct 2001
ARTHROCARE ELECTROSURGERY WANDS
K012519 · Arthrocare Corp. · Oct 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012625 · Alliance Medical Corp. · Oct 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · Aesculap, Inc. · Oct 2001