Cleared Traditional

DEKALB (K944414) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944414 · Endotec, Inc. · General & Plastic Surgery device
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Sep 1994
Decision
19d
Days
Class 2
Risk

K944414 is an FDA 510(k) clearance for the DEKALB. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Endotec, Inc. (Norcross, US). The FDA issued a Cleared decision on September 27, 1994 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Endotec, Inc. devices

Submission Details

510(k) Number K944414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1994
Decision Date September 27, 1994
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCJ Laparoscope, General & Plastic Surgery

All 357
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K944414.
KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
K945059 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD
K945101 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
K944467 · Aesculap, Inc. · Oct 1994
KARL STORZ FLUID LIGHT CABLES
K944224 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH
K935277 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE
K935279 · KARL STORZ Endoscopy-America, Inc. · Sep 1994