Cleared Traditional

8MM TROCAR KIT (K133845) - FDA 510(k) Clearance

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

K133845 · Intuitive Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
63d
Days
Class 2
Risk

K133845 is an FDA 510(k) clearance for the 8MM TROCAR KIT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Intuitive Surgical (Sunnyvale, US). The FDA issued a Cleared decision on February 19, 2014 after a review of 63 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.

View all Intuitive Surgical devices

Submission Details

510(k) Number K133845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date February 19, 2014
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 439
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K133845.
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K140593 · Cook, Inc. · Dec 2014
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
K142547 · Covidien · Dec 2014
SINGLE-SITE PORT
K133203 · Intuitive Surgical, Inc. · May 2014
SHORT PORT BLUNT TIP TROCAR
K130121 · Boston Scientific Corporation · Apr 2013
SOVEREIGN MINI
K123102 · Aesculap, Inc. · Jan 2013
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
K120468 · Cook Incorporated · Jul 2012