Cleared Traditional

K024011 - SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES (FDA 510(k) Clearance)

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

K024011 · Surgical Instruments Service and Savings, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
15d
Days
Class 2
Risk

K024011 is an FDA 510(k) clearance for the SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURG.... Classified as Forceps, Biopsy, Electric, Reprocessed (product code NLU), Class II - Special Controls.

Submitted by Surgical Instruments Service and Savings, Inc. (Sisters, US). The FDA issued a Cleared decision on December 19, 2002 after a review of 15 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 Surgical Instruments Service and Savings, Inc. devices

Submission Details

510(k) Number K024011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date December 19, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.