Cleared Traditional

K941092 - MURDOCH LAPAROSCOPE LENS CLEANER

K941092 is the FDA 510(k) clearance for MURDOCH LAPAROSCOPE LENS CLEANER by Cook, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K941092 · Cook, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
34d
Days
Class 2
Risk

K941092 is an FDA 510(k) clearance for the MURDOCH LAPAROSCOPE LENS CLEANER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 11, 1994 after a review of 34 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.

View all Cook, Inc. devices

Submission Details

510(k) Number K941092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date April 11, 1994
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 K941092.
AESCULAP TROCAR COLLAR
K941024 · Aesculap, Inc. · Apr 1994
LAPAROSCOPY INSTRUMENTS
K931778 · Buckman Co., Inc. · Apr 1994
ACUFEX VIDEO SYSTEM
K940241 · Acufex Microsurgical, Inc. · Apr 1994
AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
K940398 · United States Surgical, A Division of Tyco Healthc · Apr 1994
PISTOL SUCTION/IRRIGATION PROBE
K930813 · Origin Medsystems, Inc. · Mar 1994
GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT
K940439 · Conmedcorp · Mar 1994