Cleared Traditional

K913848 - SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K913848 · Sharplan Lasers, Inc. · Obstetrics & Gynecology device
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Mar 1992
Decision
213d
Days
Class 3
Risk

K913848 is an FDA 510(k) clearance for the SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR. Classified as Aspirator, Ultrasonic (product code MGI), Class III - Premarket Approval.

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 213 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K913848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date March 27, 1992
Days to Decision 213 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 160d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGI Aspirator, Ultrasonic
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.