Cleared Traditional

K050163 - HENKE SASS WOLF OF AMERICA BARIATRIC LA...

K050163 is an FDA 510(k) clearance for HENKE SASS WOLF OF AMERICA BARIATRIC LA..., manufactured by Henke Sass Wolf of America, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K050163 · Henke Sass Wolf of America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
58d
Days
Class 2
Risk

K050163 is an FDA 510(k) clearance for the HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Henke Sass Wolf of America, Inc. (Flemington, US). The FDA issued a Cleared decision on March 24, 2005 after a review of 58 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 Henke Sass Wolf of America, Inc. devices

FDA 510(k) Submission Details - K050163

510(k) Number K050163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2005
Decision Date March 24, 2005
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 K050163.
ENDOSCOPIC APPLICATOR
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K050639 · Lumenis, Inc. · Mar 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · Micromedics, Inc. · Feb 2005
MODIFIED SPACEMAKER SYSTEM
K042412 · United States Surgical, A Division of Tyco Healthc · Sep 2004
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
K041795 · Applied Medical Resources Corp. · Sep 2004