Cleared Traditional

K944823 - KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES

K944823 is an FDA 510(k) clearance for KARL STORZ INSULATED DISSECTING CANNULAE, manufactured by Karl Storz Endoskop GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K944823 · Karl Storz Endoskop GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
34d
Days
Class 2
Risk

K944823 is an FDA 510(k) clearance for the KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Karl Storz Endoskop GmbH (Culver City, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 34 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karl Storz Endoskop GmbH devices

FDA 510(k) Submission Details - K944823

510(k) Number K944823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1994
Decision Date November 02, 1994
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1750
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K944823.
E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS
K945260 · Valleylab, Inc. · Nov 1994
DISPOSABLE & REUSABLE CHUCK HANDLE
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KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES
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MINI-OP LAPAROSCOPIC LASSO
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KARL STORZ INSULATED SCISSORS AND RECTAL SNARES
K944530 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
IRRIGATION/BIPOLAR SET
K942944 · Surgin Surgical Instrumentation, Inc. · Sep 1994