Cleared Traditional

K974391 - KARL STORZ ENDOVISION XL ENDOSCOPIC CAM...

K974391 is an FDA 510(k) clearance for KARL STORZ ENDOVISION XL ENDOSCOPIC CAM..., manufactured by Karl Storz Imaging, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K974391 · Karl Storz Imaging, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
70d
Days
Class 2
Risk

K974391 is an FDA 510(k) clearance for the KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Karl Storz Imaging, Inc. (Goleta, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 70 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 Imaging, Inc. devices

FDA 510(k) Submission Details - K974391

510(k) Number K974391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date January 30, 1998
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K974391.
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · Ethicon Endo-Surgery, Inc. · Mar 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc. · Feb 1998
MENTOR SKIN PROTECTION PAD
K980050 · Mentor Corp. · Feb 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · Smith & Nephew, Inc. · Jan 1998
KSEA PLASTIC TROCARS
K974366 · Karl Storz Endoscopy · Jan 1998
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
K973359 · Richard Wolf Medical Instruments Corp. · Nov 1997