510(k) Report

510(k) · Cleared

Cleared

Sharplan Model Ultra Ultrasonic Surg Aspirator

K913848510(k) TraditionalCleared Mar 27, 1992213-day reviewClass III

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sharplan Lasers, Inc. · MGI Aspirator, Ultrasonic

Cleared on Mar 27, 1992 after a 213-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 27, 1992
Review
213 days
Class
Class III
Product code
MGI
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K913848Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MGI devices

MGI Aspirator, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGI

FDA has decided no MGI device since 2007.

Median 510(k) review, days · MGI

Too few MGI 510(k)s in any year since 2007 to give a median.

Recalls per year · MGI

No recall names MGI since 2007.

Adverse event reports per year · MGI

1in 2014

2013: 32014: 1
2007high 3 (2013) · low 0 (2007)2025

MAUDE reports naming product code MGI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—03
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sharplan Lasers, Inc.

78 FDA decisions under this applicant name. See the company

  • K973354Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  • K972099Sharplan Epitouch Ruby Laser SystemSharplan Lasers, Inc. · 1997
  • K971874Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  • K971648Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
  • K971743Sharplan CO2 Surgical Laser SystemSharplan Lasers, Inc. · 1997

https://510kreport.com/device/K913848 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913848: Sharplan Model Ultra Ultrasonic Surg Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913848

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026