Cleared Traditional

K021747 - DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR

K021747 is an FDA 510(k) clearance for DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR, manufactured by Surgicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K021747 · Surgicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
79d
Days
Class 2
Risk

K021747 is an FDA 510(k) clearance for the DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by Surgicon, Inc. (Stratford, US). The FDA issued a Cleared decision on August 15, 2002 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K021747

510(k) Number K021747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date August 15, 2002
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCI Device Classification - Class 2, Special Controls

Product Code GCI Laryngoscope, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCI Laryngoscope, Endoscope

All 13
Devices cleared under the same product code (GCI) and FDA review panel - the closest regulatory comparables to K021747.
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K003222 · Computer Motion, Inc. · Nov 2000
KARL STORZ 3D VIDEO SYSTEM
K001362 · Karl Storz Imaging, Inc. · Jul 2000
BIRTCHER SURE CLEAN INSTRUMENT SYSTEM
K930302 · Birtcher Medical Systems, Inc. · Oct 1993
BOOTY ENDOSCOPE WARMER
K933515 · T-Med, Inc. · Oct 1993
GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
K930496 · Birtcher Medical Systems, Inc. · Apr 1993
AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
K922123 · United States Surgical, A Division of Tyco Healthc · Feb 1993
K021747 · DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
Download PDF FDA Summary Surgicon, Inc.