# K101711: Ceruleau Electrosurgical Probe

- Pathway: 510(k) (Traditional)
- Applicant: Nuortho Surgical, Inc.
- Decided: Jul 1, 2010 after 13 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944992 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011083: Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand, Arthrocare Corp. (2001) Summary page 1.
- K991960: Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch, Stryker Endoscopy (1999) Summary page 1.
- K002422: Varpr 3.5MM 90 Suction Electrode for Use with Vapr System, Mitek Products (2000) Summary page 1.
- K993885: Ultrablator Electrode, Linvatec Corp. (2000). Our reading of the summary gave K993685, FDA’s number for Biopack (Bioscan, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ConMed UltrAblator”.
- K012018: Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910, Acmi Corporation (2002) Summary page 1.

## Indications for use
The NuOrtho CERULEAU Probes are indicated for resection, coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. These procedures include the following indications: Resection and Excision: Acetabular Labrum (Hip); Articular Labrum (All Joints); Capsule (All Joints); Capsular Release (Knee); Cartilage Flaps (Knee); Cysts (All Joints); Discoid Meniscus (Knee); Frozen Shoulder Release (Shoulder); Glenoid Labrum (Shoulder); Labral Tear (Shoulder); Lateral Release (Knee); Ligament (All Joints); Loose Bodies (All Joints); Meniscal Cystectomy (Knee); Meniscectomy (Knee); Plica Removal (All Joints); Scar Tissue (All Joints); Soft Tissue (All Joints); Synovial Membrane (All Joints); Tendon (All Joints); Triangular Fibrocartilage (TFCC) (Wrist); Villusectomy (Knee). Debridement: ACL/PCL (Knee); Acromioplasty (Shoulder); Articular Cartilage (All Joints); Bursectomy (All Joints); Chondroplasty (All Joints); Facia (All Joints); Ligament (All Joints); Notchplasty (Knee); Scar Tissue (All Joints); Soft Tissue (All Joints); Subacromial Decompression (Shoulder); Synovectomy (All Joints); Tendon (All Joints). Coagulation: ACL/PCL (Knee); Articular Cartilage (All Joints); Carpal Ligaments (Wrist); Glenohumeral Capsule (Shoulder); Ligament (All Joints); Medial Retinaculum (Knee); Rotator Cuff (Shoulder); Tendon (All Joints); Wrist Tendons (Wrist).

Source page: https://510kreport.com/device/K101711
Methodology: https://510kreport.com/methodology