Cleared Traditional

K063531 - SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM

K063531 · Sra Developments, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
92d
Days
-
Risk

K063531 is an FDA 510(k) clearance for the SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Sra Developments, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on February 22, 2007 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Sra Developments, Ltd. devices

FDA 510(k) Submission Details - K063531

510(k) Number K063531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date February 22, 2007
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 146
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