510(k) · Cleared
ClearedAesculap Power System Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GET Motor, Surgical Instrument, Pneumatic Powered
Cleared on Mar 7, 1996 as substantially equivalent to K770428 (Holco Instrument Corp., 1979) and 2 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Mar 7, 1996
- Review
- 35 days
- Class
- Class I
- Product code
- GET
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K770428 (1979). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK770428 Various Surg. & Diagnostic Instru. Etc.Holco Instrument Corp. · 1979
- This deviceK960473 Aesculap Power System HandpieceAesculap, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770428 | Various Surg. & Diagnostic Instru. Etc. | Holco Instrument Corp. | 1979 | — |
| 0 (this device) | K960473 | Aesculap Power System Handpiece | Aesculap, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K770428 | Various Surg. & Diagnostic Instru. Etc.Summary page 1…ce presented in this application is a modification to an existing device. Aesculap’s modified Power System Handpiece is compared to it's predecessor which is subject to #K770428. The modified Power System Handpiece is also compared to handpieces by Hall Surgical (#K864929) and Midas Rex (#K900388). Device… | 1979 |
| * | K864929 | Hall (R) Micro E Powered Surgical Instrument SystSummary page 1…ower System Handpiece is compared to it's predecessor which is subject to #K770428. The modified Power System Handpiece is also compared to handpieces by Hall Surgical (#K864929) and Midas Rex (#K900388). Device Description The only modification to the device is in the length of the handpiece shaft which… | 1987 |
| * | K900388 | Modified Sterilization of Drills, Burrs, TrephinesSummary page 1…compared to it's predecessor which is subject to #K770428. The modified Power System Handpiece is also compared to handpieces by Hall Surgical (#K864929) and Midas Rex (#K900388). Device Description The only modification to the device is in the length of the handpiece shaft which has increased from 75mm… | 1990 |
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.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GET devicesGET Motor, Surgical Instrument, Pneumatic Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GET
FDA has decided no GET device since 2007.
Median 510(k) review, days · GET
Too few GET 510(k)s in any year since 2007 to give a median.
Recalls per year · GET
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GET
8in 2025
MAUDE reports naming product code GET, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 33 |
| 2008 | 0 | — | 47 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 35 |
| 2011 | 0 | — | 0 | 280 |
| 2012 | 0 | — | 0 | 48 |
| 2013 | 0 | — | 1 | 34 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 43 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 45 |
| 2018 | 0 | — | 0 | 46 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960473: Aesculap Power System Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960473
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026