Penlon
Reusable - ISO ‘Green’ System Diamond Fibrelight Blade (Seward, Macintosh, Robertshaw, Miller)
44manufacturers in China registered for this device type
35catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (22), Jiangsu (9), Zhejiang (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 44. All 44 manufacturers in China registered for Laryngoscope, Rigid
Record
| Listed by | Penlon Ltd., United Kingdom |
|---|---|
| FDA product code | CCW |
| Device type | Laryngoscope, Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-06 |
| Record revised | 2026-07-28 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Peracetic Acid, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-08-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 408001006 | In distribution | |
| 408001007 | In distribution | |
| 408001025 | In distribution | |
| Crystal Metal Disposable Handle | In distribution | |
| 408001010 | In distribution | |
| McCoy laryngoscope Blade, Handle | In distribution | |
| 408001005 | In distribution | |
| ISO ‘Green’ System MRI Blade | In distribution | |
| Crystal Metal Disposable Blade | In distribution | |
| Premier Conventional Blade | In distribution | |
| Green System MRI Standard Handle | In distribution | |
| Premier Fibrelight ISO ‘Red’ Handle | In distribution | |
| Diamond Fibrelight ISO ‘Green’ type Handle | In distribution | |
| ISO ‘Green’ System Diamond Fibrelight Blade Set 1 & 2 | In distribution | |
| ISO ‘Red’ System Premier Fibrelight Blade | In distribution | |
| 408001009 | In distribution | |
| 408001008 | In distribution | |
| Premier Conventional Handle | In distribution | |
| ISO ‘Green’ System Diamond Fibrelight Blade | In distribution | |
| 408001015 | Withdrawn | |
| 408001001 | Withdrawn | |
| 408001021 | Withdrawn | |
| 408001018 | Withdrawn | |
| 408001016 | Withdrawn | |
| 408001011 | Withdrawn | |
| 408001004 | Withdrawn | |
| 408001013 | Withdrawn | |
| 408001022 | Withdrawn | |
| 408001014 | Withdrawn | |
| 408001017 | Withdrawn | |
| 408001002 | Withdrawn | |
| 408001019 | Withdrawn | |
| 408001020 | Withdrawn | |
| 408001004 | Withdrawn | |
| 408001012 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 509 |
| SunMed | SunMed Group Holdings, LLC | 255 |
| Ambler Surgical | Ambler Surgical, LLC | 192 |
| AincA® | Anesthesia Associates, Inc. | 186 |
| Curaplex | Bound Tree Medical, LLC | 172 |
| GlideScope® | Verathon Medical (Canada) ULC | 166 |
| Pilling | Teleflex Medical LLC | 163 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 157 |
| Laryngoscope, Rigid | Karl Storz GmbH & Co. KG | 140 |
| Medline | Medline Industries, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 111 |
| Sklar® | Sklar Corporation | 92 |
Showing 12 of 442. All products under Laryngoscope, Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953179 | 1995-10-06 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-09-21 | Not classified | Error in labeling | Disposable laryngoscope blades incorrectly labeled with wrong size. | 24,940 cartons | 2012-06-19 |
| 2011-03-10 | Not classified | Other | Disposable laryngoscope blades incorrectly labeled with wrong size. | 5 cartons (20 blades each) | 2012-09-21 |
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.