Cleared Traditional

K953399 - NEEDLE OR CUTTER

K953399 is an FDA 510(k) clearance for NEEDLE OR CUTTER, manufactured by Biophysic Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K953399 · Biophysic Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
102d
Days
Class 2
Risk

K953399 is an FDA 510(k) clearance for the NEEDLE OR CUTTER. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Biophysic Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biophysic Medical, Inc. devices

FDA 510(k) Submission Details - K953399

510(k) Number K953399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date October 30, 1995
Days to Decision 102 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
29d faster than avg
Panel avg: 131d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 301
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K953399.
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