# K100543: Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01

- Pathway: 510(k) (Traditional)
- Applicant: Medisiss
- Decided: Jul 23, 2010 after 148 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K936109 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070374: Arthrocare Ent Plasma Wand, Arthrocare Corp. (2007) Summary page 1.
- K014290: Entec Plasma Wands, Arthrocare Corp. (2002) Summary page 1.
- K063538: Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands, Arthrocare Corp. (2006) Summary page 1.
- K013463: Arthrocare Arthro Wands, Enetec Evac Plasma Wand, Arthrocare Corp. (2001) Summary page 1.
- K012669: Reprocessed Electrosurgical Electrodes, Surgical Instruments Service and Savings, Inc. (2002) Summary page 1.

## Recalls of this device
- Mar 5, 2025 · Class II · Z-1548-2025: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

## Indications for use
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.

Source page: https://510kreport.com/device/K100543
Methodology: https://510kreport.com/methodology