Cleared Traditional

K001666 - MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM

K001666 is an FDA 510(k) clearance for MODIFICATION TO INTUITIVE SURGICAL STER..., manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K001666 · Intuitive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
85d
Days
Class 2
Risk

K001666 is an FDA 510(k) clearance for the MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 85 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 - K001666

510(k) Number K001666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2000
Decision Date August 24, 2000
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K001666.
ELRAN 01 SYSTEM
K002431 · Envision Advanced Medical System, Ltd. · Oct 2000
REUSABLE CANNULA
K002542 · Genicon, LC · Oct 2000
OMNIPORT
K002013 · Advanced Surgical Concepts (Asc) · Sep 2000
CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
K992182 · Ca Guard, Ltd. · Jul 2000
3.5 MM LAPAROSCOPE (LG100, LG103)
K001594 · Surgical Image Laboratories, Inc. · Jun 2000
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
K001597 · Conmedcorp · Jun 2000
K001666 · MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
Download PDF FDA Summary Intuitive Surgical, I…