Cleared Traditional

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE (K100109) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100109 · Surgical Innovations Plc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
182d
Days
Class 2
Risk

K100109 is an FDA 510(k) clearance for the LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Surgical Innovations Plc (Leeds, GB). The FDA issued a Cleared decision on July 15, 2010 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Innovations Plc devices

Submission Details

510(k) Number K100109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2010
Decision Date July 15, 2010
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1420
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K100109.
TroKit Laparoscope Lens Wiper
K253994 · TroCare, LLC · Jun 2026
Inno-Port Disposable Bladed Trocar
K252532 · Taiwan Surgical Corporation · Jun 2026
4K NIR/ICG Imaging System
K260318 · Zhejiang Healnoc Technology Co., Ltd. · May 2026
MediBot Needle Driver Uno
K260183 · Parallel Robotics, LLC · May 2026
Laport
K252985 · Sejong Medical Co., Ltd. · May 2026
KARL STORZ Trocars with Valve Seals
K254228 · Karl Storz SE & CO. KG · May 2026