Cleared Traditional

K935815 - ERBOTOM ICC 50

K935815 is the FDA 510(k) clearance for ERBOTOM ICC 50 by Erbe USA, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K935815 · Erbe USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
119d
Days
Class 2
Risk

K935815 is an FDA 510(k) clearance for the ERBOTOM ICC 50. 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. (Lawrenceville, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 119 days - within the typical 510(k) review window.

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 Erbe USA, Inc. devices

Submission Details

510(k) Number K935815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date March 31, 1994
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 1130
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K935815.
TITANIUM BIPOLAR FORCEPS
K940466 · Radionics, Inc. · Apr 1994
AESCULAP ENDOSCOPIC INSTRUMENTS
K940936 · Aesculap, Inc. · Apr 1994
CONMED T.D.S. ELECTROSURGICAL GROUND PAD
K941160 · Conmedcorp · Apr 1994
STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIES
K935222 · Stryker Endoscopy · Mar 1994
STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
K935237 · Stryker Endoscopy · Mar 1994
ERBOTOM ICC 350
K933002 · Erbe USA, Inc. · Mar 1994