Cleared Abbreviated

MICTEC ENDOSCOPES AND ACCESSORIES (K002877) - FDA 510(k) Clearance

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

K002877 · Dufner Instrumente GmbH · General & Plastic Surgery device
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Feb 2001
Decision
143d
Days
Class 2
Risk

K002877 is an FDA 510(k) clearance for the MICTEC ENDOSCOPES AND ACCESSORIES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Dufner Instrumente GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on February 5, 2001 after a review of 143 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dufner Instrumente GmbH devices

Submission Details

510(k) Number K002877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2000
Decision Date February 05, 2001
Days to Decision 143 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
Pathway characteristics
Standards-based clearance path.

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 K002877.
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