PNEUMATIC CUTTER SYSTEM— 510(k) K983050
Substantially EquivalentSurgical Laser Technologies, Inc.
FDA 510(k) clearance K983050 for PNEUMATIC CUTTER SYSTEM, Substantially Equivalent on 1998-11-25. Applicant: Surgical Laser Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Laser Technologies, Inc.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montgomeryville, PA, US
Recent devices under product code ERL
view allMore clearances from Surgical Laser Technologies, Inc.
view all- K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
- K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
- K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM
- K010041 — SLT DIFFUSER FIBER
- K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.