510(k) · Cleared
Recalled · 2008Reprocessed RF Arthroscopy Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 8, 2001 as substantially equivalent to K992581 (Arthrocare Corp., 1999) and 4 other predicates after an 86-day review. Its family tree reaches back 6 generations to 1995. It has been recalled once.
- Decided
- Nov 8, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 6 generations to K943450 (1995). 23 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 1 generation backK992581 Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…Arthrocare Corp. · 1999
- This deviceK012679 Reprocessed RF Arthroscopy ProbesSterilmed, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −5 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −1 | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands… | Arthrocare Corp. | 1999 | — |
| 0 (this device) | K012679 | Reprocessed RF Arthroscopy Probes | Sterilmed, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Summary page 1…Reprocessed RF Arthroscopy Probes are substantially equivalent to the Arthroscopy Probes packaged with: o ArthroCare Corp.’s ArthroCare Orthopedic Electrosurgery System (K992581); ¢ Oratec Interventions, Inc.’s Vulcan™ EAS™ ElectroThermal Arthroscopy System and Accessories (K991140); ¢ Mitek®Products Vap… | 1999 |
| * | K991140 | Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System and AccessoriesSummary page 1…ArthroCare Corp.’s ArthroCare Orthopedic Electrosurgery System (K992581); ¢ Oratec Interventions, Inc.’s Vulcan™ EAS™ ElectroThermal Arthroscopy System and Accessories (K991140); ¢ Mitek®Products Vapr ™ System and Accessory Electrosurgical Electrodes (K974022) (K992876) (K002422); and e To their counter… | 1999 |
| * | K974022 | VAPRSummary page 1…Interventions, Inc.’s Vulcan™ EAS™ ElectroThermal Arthroscopy System and Accessories (K991140); ¢ Mitek®Products Vapr ™ System and Accessory Electrosurgical Electrodes (K974022) (K992876) (K002422); and e To their counterparts from the original manufacturers. Device Description: SterilMed’s reprocessed… | 1998 |
| * | K992876 | Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemSummary page 1…ons, Inc.’s Vulcan™ EAS™ ElectroThermal Arthroscopy System and Accessories (K991140); ¢ Mitek®Products Vapr ™ System and Accessory Electrosurgical Electrodes (K974022) (K992876) (K002422); and e To their counterparts from the original manufacturers. Device Description: SterilMed’s reprocessed RF Arthros… | 1999 |
| * | K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemSummary page 1…s Vulcan™ EAS™ ElectroThermal Arthroscopy System and Accessories (K991140); ¢ Mitek®Products Vapr ™ System and Accessory Electrosurgical Electrodes (K974022) (K992876) (K002422); and e To their counterparts from the original manufacturers. Device Description: SterilMed’s reprocessed RF Arthroscopy Probe… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0568-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 4 other devices also cite its predicate K992581.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
These devices are designed for general surgical use, including orthopedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissue. Arthroscopic surgery may include:
Knee
Shoulder
Ankle
Elbow
Wrist
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/K012679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012679: Reprocessed RF Arthroscopy Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012679
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026