Cleared Traditional

K945796 - SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRA...

K945796 is the FDA 510(k) clearance for SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRA... by Sharplan Lasers, Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K945796 · Sharplan Lasers, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
177d
Days
Class 2
Risk

K945796 is an FDA 510(k) clearance for the SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 177 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K945796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date May 24, 1995
Days to Decision 177 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 107d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 202
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K945796.
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