REPROCESSED ELECTROSURGICAL ELECTRODES
FDA 510(k) clearance K012669 · decided 2002-06-27
Clearance details
- K-number
- K012669
- Device name
- REPROCESSED ELECTROSURGICAL ELECTRODES
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2002-06-27
- Days to decision
- 318 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated recall (Z-1546-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-04-09 |
| MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF recall (Z-1547-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-04-09 |
| MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), I recall (Z-1549-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-04-09 |
| -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm recall (Z-1628-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |
| Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5. recall (Z-1644-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |