Cleared Traditional

K940790 - BABCOCK/BOWEL CLAMP FORCEPS

K940790 is the FDA 510(k) clearance for BABCOCK/BOWEL CLAMP FORCEPS 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 254-day FDA review.

K940790 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Nov 1994
Decision
254d
Days
Class 2
Risk

K940790 is an FDA 510(k) clearance for the BABCOCK/BOWEL CLAMP FORCEPS. 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 3, 1994 after a review of 254 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 K940790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date November 03, 1994
Days to Decision 254 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
139d slower than avg
Panel avg: 115d · This submission: 254d
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 K940790.
SUCTION AND IRRIGATION TUBES
K940960 · Richard Wolf Medical Instruments Corp. · Nov 1994
CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS
K943327 · Conmedcorp · Nov 1994
ORIGIN PIXIE STIC INTRODUCER SLEEVE
K945023 · Origin Medsystems, Inc. · Nov 1994
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
K944467 · Aesculap, Inc. · Oct 1994
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
K942574 · Acufex Microsurgical, Inc. · Sep 1994
IRRIGATION/ASPIRATION INSTRUMENT
K942306 · Megadyne Medical Products, Inc. · Sep 1994