510(k) · Cleared
ClearedEBERLE Shaver System C3 and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eberle GmbH & Co. KG · HRX Arthroscope
Cleared on Jan 15, 2021 as substantially equivalent to K092977 (Efs Eberle Feinwerktechnische Systeme, 2010) after a 386-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Jan 15, 2021
- Review
- 386 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931783 (1993). 40 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 4 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 3 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 2 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 1 generation backK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
- This deviceK193608 EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −4 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −3 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −2 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −1 | K092977 | Eberle Shaver System Accessories | Efs Eberle Feinwerktechnische Systeme | 2010 | — |
| 0 (this device) | K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 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 HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K092977 | Eberle Shaver System AccessoriesSummary page 6…usively as a system. EBERLE Shaver System C2 and C3 use the same shaver blades. The shaver blades are identical with the once already cleared under the predicated device K092977 - Eberle Shaver System Accessories. Eberle has added addition blades to provide a broader offering. EBERLE Shaver System C2 and… | 2010 |
| * | — | EBERLE Shaver System C2 and Shaver Blades Named without a submission number |
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 40 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The EBERLE shaver system C3 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone.
The EBERLE shaver system accessories are designed to use with the EBERLE shaver system for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.”
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/K193608 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193608: EBERLE Shaver System C3 and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193608
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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