Laser Bronchoscope System
FDA 510(k) K861921 · Pilling Co.
510(k) numberK861921
Submission
- Device name
- Laser Bronchoscope System
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- May 19, 1986
- Decision date
- June 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLO – Laser, Neodymium:Yag, Pulmonary Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884815 | SLT CLMD Contact LaserLLO · Traditional | Surgical Laser Technologies, Inc. | 12/22/1988SE |
| K881499 | Surgilase Yag 100 for Gynecology UseLLO · Traditional | Surgilase, Inc. | 04/29/1988SE |
| K880592 | Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional | Laser Peripherals, LLC | 04/25/1988SE |
| K880170 | Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | Cooper Lasersonics, Inc. | 03/24/1988SE |
| K874254 | Nd:Yag Surgical Laser for Pulmonary ApplicationsLLO · Traditional | Minnesota Laser Corp. | 03/04/1988SE |
| K875104 | Surgi-Light Disposable System for Pulmonology UseLLO · Traditional | Laserguide | 02/02/1988SE |
| K871876 | Model 5050 Surgilaser for Pulmonary UseLLO · Traditional | Lasermatic, Inc. | 01/22/1988SE |
| K872351 | Fiberlase II Nd:Yag Laser for Pulmonary UseLLO · Traditional | Laser Media | 12/11/1987SE |
| K870505 | Optilase Yag Model 1000 Surg Laser Sys/Pulmon ApplLLO · Traditional | Trimedyne, Inc. | 08/07/1987SE |
| K871511 | SL-100 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | Medical Energy, Inc. | 07/21/1987SE |
More from Medical Energy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002582 | Pilling E-Frazier Bipolar Suction TubeGEI · Traditional | 11/03/2000SE |
| K934427 | Pilling Laparoscopic InstrumentationGEI · Traditional | 01/10/1994SE |
| K925370 | Triangular Jaw Microlaryngeal ForcepsELW · Traditional | 03/18/1993SE |
| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | 11/21/1991SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
Questions and answers
When was Laser Bronchoscope System cleared by the FDA?
Laser Bronchoscope System (K861921) received a 510(k) decision of Substantially Equivalent on June 2, 1986, 14 days after the submission was received.
What is the product code of K861921?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.