Cleared Special

K052802 - MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE

K052802 is an FDA 510(k) clearance for MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE, manufactured by Manan Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 29-day FDA review.

K052802 · Manan Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
29d
Days
Class 2
Risk

K052802 is an FDA 510(k) clearance for the MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Wheeling, US). The FDA issued a Cleared decision on November 1, 2005 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K052802

510(k) Number K052802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date November 01, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KNW Device Classification - Class 2, Special Controls

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 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K052802.
RUBICOR MAGIC BREAST BIOPSY DEVICE
K053151 · Rubicor Medical, Inc. · Nov 2005
ABBOTT SPINE, INC. SPINNAKER SYSTEM
K052638 · Abbott Spine, Inc. · Nov 2005
PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS
K052435 · Pneumrx, Inc. · Nov 2005
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
K051581 · Sanarus Medical, Inc. · Jul 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · Boston Scientific Corp · Jun 2005
IMBIBE BONE MARROW ASPIRATION NEEDLE
K050795 · Orthovita, Inc. · Jun 2005