Cleared Traditional

KSEA PLASTIC TROCARS (K974366) - FDA 510(k) Clearance

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

K974366 · Karl Storz Endoscopy · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
49d
Days
Class 2
Risk

K974366 is an FDA 510(k) clearance for the KSEA PLASTIC TROCARS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 49 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 Karl Storz Endoscopy devices

Submission Details

510(k) Number K974366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date January 08, 1998
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 356
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K974366.
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · Smith & Nephew, Inc. · May 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc. · Feb 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · Smith & Nephew, Inc. · Jan 1998
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
K972471 · Smith & Nephew, Inc. · Oct 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · Smith & Nephew, Inc. · Aug 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · KARL STORZ Endoscopy-America, Inc. · Aug 1997