Cleared Abbreviated

K003717 - INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF

K003717 is an FDA 510(k) clearance for INSTRUMENTS FOR LAPAROSCOPY 5 MM, manufactured by Tekno Medical Optik-Chirurgie GmbH & Co.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Abbreviated 510(k) pathway after a 87-day FDA review.

K003717 · Tekno Medical Optik-Chirurgie GmbH & Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
87d
Days
Class 2
Risk

K003717 is an FDA 510(k) clearance for the INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDO.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Tekno Medical Optik-Chirurgie GmbH & Co. (Wurmlingen, DE). The FDA issued a Cleared decision on March 1, 2001 after a review of 87 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 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 Tekno Medical Optik-Chirurgie GmbH & Co. devices

FDA 510(k) Submission Details - K003717

510(k) Number K003717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date March 01, 2001
Days to Decision 87 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 faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 1702
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K003717.
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
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ENDIUS BIPOLAR SHEATH
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K010444 · C.R. Bard, Inc. · Feb 2001
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045
K003462 · Erbe USA, Inc. · Jan 2001
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K001955 · Aaron Medical Industries · Dec 2000