Cleared Traditional

K072211 - INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS

K072211 is an FDA 510(k) clearance for INTUITIVE SURGICAL INSTRUMENT AND ACCES..., manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K072211 · Intuitive Surgical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
203d
Days
Class 2
Risk

K072211 is an FDA 510(k) clearance for the INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 28, 2008 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

FDA 510(k) Submission Details - K072211

510(k) Number K072211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2007
Decision Date February 28, 2008
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
MORTEN S CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K072211.
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · Smith & Nephew, Inc. · Mar 2009
CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
K080531 · Conmed Linvatec · Sep 2008
AESCULAP PRIMELINE CONTAINER LTD.
K073168 · Aesculap, Inc. · Apr 2008
MILTEX RIGID CONTAINER SYSTEMS
K072563 · Miltex, Inc. · Feb 2008
VIS-U-ALL II SELF SEAL POUCH
K070765 · STERIS Corporation · Oct 2007
VHP 136 TRAY
K070769 · STERIS Corporation · Oct 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.