Cleared Special

K010779 - MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC...

K010779 is an FDA 510(k) clearance for MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC..., manufactured by Gibbons Surgical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FHO cleared through the Special 510(k) pathway after a 26-day FDA review.

K010779 · Gibbons Surgical Corp. · Gastroenterology & Urology device
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Apr 2001
Decision
26d
Days
Class 2
Risk

K010779 is an FDA 510(k) clearance for the MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT. Classified as Pneumoperitoneum Needle (product code FHO), Class II - Special Controls.

Submitted by Gibbons Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on April 10, 2001 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Gibbons Surgical Corp. devices

FDA 510(k) Submission Details - K010779

510(k) Number K010779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2001
Decision Date April 10, 2001
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

FHO Device Classification - Class 2, Special Controls

Product Code FHO Pneumoperitoneum Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition For Establishment Of A Pneumoperitoneum In Abdomen.
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 - FHO Pneumoperitoneum Needle

Devices cleared under the same product code (FHO) and FDA review panel - the closest regulatory comparables to K010779.
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
K960574 · Sherwood Medical Co. · Aug 1996
VERRES NEEDLE
K942484 · Linvatec Corp. · Jun 1994
ORIGINEEDLE, MODIFICATION
K913816 · Origin Medsystems, Inc. · Nov 1991
ORIGINEEDLE(TM)
K904849 · Origin Medsystems, Inc. · Mar 1991
DISPOSABLE PNEUMOPERITONEUM NEEDLE
K863330 · United States Surgical, A Division of Tyco Healthc · Oct 1986