Laryngoscope, Non-Rigid
FDA product code CAL · Class I (low risk) · 21 CFR 868.5530 · Anesthesiology
8510(k) clearances
0PMA approvals
11recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951195 | FI-10PCAL · Traditional | Pentax Precision Instrument Corp. | 04/06/1995SE |
| K951194 | FI-10MCAL · Traditional | Pentax Precision Instrument Corp. | 04/06/1995SE |
| K872895 | Haemonetics Cell Saver Mini Saver Auto. Blood Sys.CAL · Traditional | Haemonetics Corp. | 01/11/1988SE |
| K852994 | Reichert Flexible Laryngoscope, Model LS-11CAL · Traditional | Reichert-Jung, Inc. | 07/29/1985SE |
| K850978 | Olympus LF-1 Intubation ScopeCAL · Traditional | Olympus Corp. | 05/23/1985SE |
| K802331 | Ao Flexible Laryngoscope, #LS-7CAL · Traditional | American Optical Corp. | 10/10/1980SE |
| K801364 | Ao Stylet Laryngoscope Model SLSCAL · Traditional | American Optical Corp. | 06/17/1980SE |
| K791634 | Ao Stylet Laryngoscope, Model SLS-1CAL · Traditional | American Optical Corp. | 09/17/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0184-2022 Class II | FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6…During a regular requalification review, affected flexible intubation video endoscopes did not achieve the… | Karl Storz Endoscopy | 09/10/2021Open, Classified |
| Z-2897-2020 Class II | Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2896-2020 Class II | Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2895-2020 Class II | Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2894-2020 Class II | Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2893-2020 Class II | Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2892-2020 Class II | Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2891-2020 Class II | Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2890-2020 Class II | Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US -…Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not… | Karl Storz Endoscopy | 07/27/2020Open, Classified |
| Z-2072-2016 Class II | Intubation Scope Intended to provide optical visualization of, therapeutic access to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-0526-2014 Class II | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2…KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation… | Karl Storz Endoscopy America Inc | 11/13/2013Terminated |