Cleared Traditional

K002546 - CIV-FLEX HOLSTER COVER

K002546 is the FDA 510(k) clearance for CIV-FLEX HOLSTER COVER by CIVCO Medical Instruments Co., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K002546 · CIVCO Medical Instruments Co., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
75d
Days
Class 2
Risk

K002546 is an FDA 510(k) clearance for the CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on October 31, 2000 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 CIVCO Medical Instruments Co., Inc. devices

Submission Details

510(k) Number K002546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 31, 2000
Days to Decision 75 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 130d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 166
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K002546.
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · Ethicon Endo-Surgery, Inc. · Jan 2001
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · Allegiance Healthcare Corp. · Nov 2000
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
K992813 · Ethicon Endo-Surgery, Inc. · Nov 1999
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
K991980 · Ethicon Endo-Surgery, Inc. · Aug 1999
AUTO SUTURE ABBI SYSTEM
K983296 · United States Surgical, A Division of Tyco Healthc · Jun 1999