Cleared Traditional

K000424 - S51D DIGITAL ENDOSCOPY CAMERA

K000424 is an FDA 510(k) clearance for S51D DIGITAL ENDOSCOPY CAMERA, manufactured by Sopro. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K000424 · Sopro · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
51d
Days
Class 2
Risk

K000424 is an FDA 510(k) clearance for the S51D DIGITAL ENDOSCOPY CAMERA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Sopro (Marseille, FR). The FDA issued a Cleared decision on March 31, 2000 after a review of 51 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 Sopro devices

FDA 510(k) Submission Details - K000424

510(k) Number K000424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2000
Decision Date March 31, 2000
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
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 K000424.
KSEA MANHES PNEUMOTROCAR
K000769 · KARL STORZ Endoscopy-America, Inc. · Jun 2000
STRYKER IRRIGATION TUBE SET
K000493 · Stryker Endoscopy · May 2000
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
K000545 · Applied Medical Resources · May 2000
SUTURE CLINCH
K992852 · Applied Medical Resources · Nov 1999
BARIATRIC LAPAROSCOPE, MODEL 367
K993045 · Stryker Endoscopy · Oct 1999
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232
K992612 · Ethicon Endo-Surgery, Inc. · Oct 1999