Cleared Traditional

K940346 - SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPI...

K940346 is the FDA 510(k) clearance for SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPI... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K940346 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
107d
Days
Class 2
Risk

K940346 is an FDA 510(k) clearance for the SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on May 12, 1994 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K940346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1994
Decision Date May 12, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
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 691
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940346.
CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
K935786 · Cabot Medical Corp. · May 1994
MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
K940011 · Phx Technologies Corp. · May 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · W.L. Gore & Associates, Inc. · May 1994
CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS
K934916 · Conmedcorp · May 1994
ADJUSTABLE BALLOON DISSECTION CANNULA
K940875 · Origin Medsystems, Inc. · May 1994
MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
K935754 · Cook Urological, Inc. · May 1994