Cleared Traditional

K941967 - HSW LAPAROSCOPE AND ACCESSORIES

K941967 is an FDA 510(k) clearance for HSW LAPAROSCOPE AND ACCESSORIES, manufactured by Henke-Sass, Wolf GmbH. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K941967 · Henke-Sass, Wolf GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
24d
Days
Class 2
Risk

K941967 is an FDA 510(k) clearance for the HSW LAPAROSCOPE AND ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Henke-Sass, Wolf GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on May 16, 1994 after a review of 24 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 GmbH devices

FDA 510(k) Submission Details - K941967

510(k) Number K941967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date May 16, 1994
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 827
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K941967.
LAPAROSCOPIC/SUCTION/IRRIGATION PROBE
K935826 · Core Dynamics, Inc. · May 1994
MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
K940011 · Phx Technologies Corp. · May 1994
DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES
K936102 · Davol Inc., Sub. C. R. Bard, Inc. · May 1994
LAPAROSCOPIC COVERED SURGICAL RETRACTOR
K933497 · Advanced Surgical, Inc. · May 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · W.L. Gore & Associates, Inc. · May 1994
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940346 · KARL STORZ Endoscopy-America, Inc. · May 1994