Cleared Traditional

K161804 - LigaSure Retractable L-Hook Laparoscopi...

K161804 is an FDA 510(k) clearance for LigaSure Retractable L-Hook Laparoscopi..., manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K161804 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
78d
Days
Class 2
Risk

K161804 is an FDA 510(k) clearance for the LigaSure Retractable L-Hook Laparoscopic Sealer/Divider. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on September 16, 2016 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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.

View all Covidien devices

FDA 510(k) Submission Details - K161804

510(k) Number K161804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2016
Decision Date September 16, 2016
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1301
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K161804.
PK Morcellator
K161038 · Gyrus Acmi, Inc. · Oct 2016
Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)
K162126 · ArthroCare Corporation · Sep 2016
PK AIM
K161825 · Gyrus Acmi, Inc. · Sep 2016
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
K162047 · Covidien · Sep 2016
Enseal X1 Large Jaw Tissue Sealer
K160554 · Ethicon Endo-Surgery, LLC · Sep 2016
Arthrex Synergy RF System
K161581 · Arthrex, Inc. · Sep 2016