Cleared Traditional

K894716 - DIRECTABLE COAXIAL CATHETER SET

K894716 is the FDA 510(k) clearance for DIRECTABLE COAXIAL CATHETER SET by Cook Ob/Gyn. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K894716 · Cook Ob/Gyn · General & Plastic Surgery device
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Aug 1989
Decision
29d
Days
Class 2
Risk

K894716 is an FDA 510(k) clearance for the DIRECTABLE COAXIAL CATHETER SET. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on August 23, 1989 after a review of 29 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 Ob/Gyn devices

Submission Details

510(k) Number K894716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date August 23, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K894716.
LAPAROSCOPIC IRRIGATION PUMP
K911493 · United States Endoscopy Group, Inc. · Apr 1991
LAPAROSCOPIC SUCTION IRRIGATION TUBING SET
K911484 · United States Endoscopy Group, Inc. · Apr 1991
STRYKER LAPAROSCOPE
K910132 · Stryker Corp. · Feb 1991
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
K862611 · United States Surgical, A Division of Tyco Healthc · Jul 1986
UNIVERSAL CANNULA
K830719 · Acufex Microsurgical, Inc. · Jun 1983
TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM
K770711 · Richard Wolf Medical Instruments Corp. · Apr 1977