Laryngostroboscope
9500LX, Laryngeal Microphone "Accessory for 9500"
1manufacturer
22catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
Record
| Listed by | Pentax of America, Inc., United States |
|---|---|
| FDA product code | EQL |
| Device type | Laryngostroboscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4750 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K921184 |
| Record published | 2018-03-08 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 19.5 to 45 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7193-0400 | In distribution | |
| 2140-0028 | In distribution | |
| 9120 | In distribution | |
| 9122 | In distribution | |
| 9122B | In distribution | |
| 9118 | Length 19.5 mm | In distribution |
| 9122C | In distribution | |
| 9500LX | In distribution | |
| 9500FS | In distribution | |
| 9125 | In distribution | |
| 9122D | In distribution | |
| 9123 | In distribution | |
| 9116 | Length 35.0 mm | In distribution |
| 9124 | In distribution | |
| 9117 | Length 45.0 mm | In distribution |
| 9703 | In distribution | |
| 2140-0031 | In distribution | |
| 9121 | In distribution | |
| 9400 | In distribution | |
| 7175-6000 | In distribution | |
| 9500MC | In distribution | |
| 9500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 62 |
| Laryngostroboscope | Karl Storz GmbH & Co. KG | 7 |
| Video Laryngostroboscope | Pentax of America, Inc. | 3 |
| Olympus | Olympus Winter & IBE Gmbh | 3 |
| Rigid Scopes | Pentax of America, Inc. | 3 |
| Pulsar | Karl Storz GmbH & Co. KG | 2 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 2 |
| Optomic | Optomic España SA | 2 |
| Pentax Medical Rigid Laryngostroboscopes | Pentax of America, Inc. | 1 |
| Pentax Medical Laryngeal Stroboscope | Pentax of America, Inc. | 1 |
| Machida | Machida Endoscope Co., Ltd. | 1 |
| Laryngostroboscope | National Advanced Endoscopy Devices, Inc. | 1 |
Showing 12 of 14. All products under Laryngostroboscope
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-12-12 | Class II | Labeling design | Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108. | 2,056 (1,545 (US) and 511 (OUS)) | 2019-03-22 |
| 2016-04-06 | Class II | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s instrument channel. | 206 units | 2017-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.