510(k) · Cleared
Recalled · Class II · 2025Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisiss · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 23, 2010 as substantially equivalent to K070374 (Arthrocare Corp., 2007) and 4 other predicates after a 148-day review. Its family tree reaches back 12 generations to 1994. It has been recalled once.
- Decided
- Jul 23, 2010
- Review
- 148 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 12 generations to K936109 (1994). 60 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations between
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK100543 Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss · 2010
Show all 12 generations
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 10 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 9 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 8 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 7 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 6 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK100543 Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −11 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −9 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −8 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −7 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −6 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −3 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −2 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −1 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| 0 (this device) | K100543 | Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01 | Medisiss | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K070374 | Arthrocare Ent Plasma WandSummary page 1…urgical cutting and coagulation device and accessories, General and plastic surgery (21 CFR 878.4400), GEI K070374 ArthroCare ENT& Plasma WandSTM K014290 ArthroCare ENTec® Plasma WandSTM Predicate Devi… | 2007 |
| * | K014290 | Entec Plasma WandsSummary page 1…essories, General and plastic surgery (21 CFR 878.4400), GEI K070374 ArthroCare ENT& Plasma WandSTM K014290 ArthroCare ENTec® Plasma WandSTM Predicate Devices K063538 ArthroCare ENT® Plasma WandSTM… | 2002 |
| * | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Summary page 1…K070374 ArthroCare ENT& Plasma WandSTM K014290 ArthroCare ENTec® Plasma WandSTM Predicate Devices K063538 ArthroCare ENT® Plasma WandSTM K01 3463 ArthroCare ArthroWands®, ENTec® EVaCTM Plasma W… | 2006 |
| * | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma WandSummary page 1…K014290 ArthroCare ENTec® Plasma WandSTM Predicate Devices K063538 ArthroCare ENT® Plasma WandSTM K01 3463 ArthroCare ArthroWands®, ENTec® EVaCTM Plasma WandTM K012669 MEDISISS Reprocessed Soft… | 2001 |
| * | K012669 | Reprocessed Electrosurgical ElectrodesSummary page 1…538 ArthroCare ENT® Plasma WandSTM K01 3463 ArthroCare ArthroWands®, ENTec® EVaCTM Plasma WandTM K012669 MEDISISS Reprocessed Soft Tissue Ablators MEDISISS Reprocessed ENT Ablation Wands (Coblator… | 2002 |
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 |
|---|---|---|---|---|
| Mar 5, 2025 | Class II | Z-1548-2025 | Under Investigation by firm | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 60 ancestors have a recall of any class.
- 8 other devices also cite its predicate K070374.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
MIEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100543 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100543: Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100543
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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