Cleared Traditional

WGL ENDOSCOPIC GRASPER (K942168) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942168 · Wilson Greatbatch Technologies, Inc. · General & Plastic Surgery device
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Dec 1994
Decision
223d
Days
Class 2
Risk

K942168 is an FDA 510(k) clearance for the WGL ENDOSCOPIC GRASPER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Wilson Greatbatch Technologies, Inc. (Clarence, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 223 days - an extended review 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: 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 Wilson Greatbatch Technologies, Inc. devices

Submission Details

510(k) Number K942168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date December 13, 1994
Days to Decision 223 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
108d slower than avg
Panel avg: 115d · This submission: 223d
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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942168.
KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS
K946164 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K946023 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
K945751 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944299 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES
K944672 · Boston Scientific Corp · Dec 1994
HI-Q HAND INSTRUMENTS- UROLOGY
K944201 · Olympus America, Inc. · Nov 1994