Cleared Traditional

K940960 - SUCTION AND IRRIGATION TUBES

K940960 is the FDA 510(k) clearance for SUCTION AND IRRIGATION TUBES by Richard Wolf Medical Instruments Corp.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K940960 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Nov 1994
Decision
251d
Days
Class 2
Risk

K940960 is an FDA 510(k) clearance for the SUCTION AND IRRIGATION TUBES. 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 November 8, 1994 after a review of 251 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K940960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1994
Decision Date November 08, 1994
Days to Decision 251 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
136d slower than avg
Panel avg: 115d · This submission: 251d
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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940960.
TROCAR ( ACCESORY)
K945457 · United States Surgical, A Division of Tyco Healthc · Nov 1994
KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
K945059 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD
K945101 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS
K943327 · Conmedcorp · Nov 1994
ORIGIN PIXIE STIC INTRODUCER SLEEVE
K945023 · Origin Medsystems, Inc. · Nov 1994
BABCOCK/BOWEL CLAMP FORCEPS
K940790 · Richard Wolf Medical Instruments Corp. · Nov 1994