Cleared Traditional

K940900 - APPENDIX EXTRACTOR 8385.50

K940900 is an FDA 510(k) clearance for APPENDIX EXTRACTOR 8385.50, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K940900 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Apr 1994
Decision
55d
Days
Class 2
Risk

K940900 is an FDA 510(k) clearance for the APPENDIX EXTRACTOR 8385.50. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on April 20, 1994 after a review of 55 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.

FDA 510(k) Submission Details - K940900

510(k) Number K940900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1994
Decision Date April 20, 1994
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940900.
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ENDOFLUSH SYSTEM 1.0, 2.O, 3.0
K935207 · Specialty Medical Systems, Inc. · Apr 1994
INMAN ENDOSCOPIC BLUNT DISSECTOR
K933169 · Inman Medical Corp. · Apr 1994
TISSUE ISOLATION AND RETRIEVAL BAG
K941500 · Advanced Surgical, Inc. · Apr 1994
INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
K940232 · Innerdyne Medical, Inc. · Apr 1994
K940900 · APPENDIX EXTRACTOR 8385.50
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