Cleared Traditional

K033593 - REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033593 · Clearmedical, Inc. · Gastroenterology & Urology device
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Nov 2003
Decision
7d
Days
Class 2
Risk

K033593 is an FDA 510(k) clearance for the REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric, Reprocessed (product code NLU), Class II - Special Controls.

Submitted by Clearmedical, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Clearmedical, Inc. devices

Submission Details

510(k) Number K033593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date November 20, 2003
Days to Decision 7 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
123d faster than avg
Panel avg: 130d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NLU Forceps, Biopsy, Electric, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
Definition The "forceps, Biopsy, Electric, Reprocessed" Are Intended To Be Used Endoscopically And Use Electric Current To (1) Obtain Tissue Samples For Histopathological Examination, (2) Allow For Coagulation So As To Prevent Bleeding, And (3) Destroy The Residuum Of The Lesion Being Biopsied. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.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 Gastroenterology & Urology devices follow this clearance model.