Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMediscope Manufacturing, Inc.
US
Last updated May 23, 2026
What Mediscope Manufacturing, Inc. makes
Mediscope Manufacturing, Inc. produces surgical compression stapling devices and their associated accessories, designed for tissue approximation and ligation in minimally invasive procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mediscope Manufacturing, Inc. produce?
Mediscope Manufacturing, Inc. specializes in surgical compression stapling devices and their associated accessories. These devices are specifically designed for tissue approximation and ligation, which are critical steps in minimally invasive surgical procedures to close off blood vessels or tissues securely.
Where is Mediscope Manufacturing, Inc. based?
Mediscope Manufacturing, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US-based medical device standards.
How are Mediscope Manufacturing, Inc.’s devices classified under FDA regulations?
Mediscope Manufacturing, Inc.’s devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The classification ensures that these devices undergo rigorous evaluation to mitigate potential risks.
Which regulatory registries or databases list Mediscope Manufacturing, Inc.’s devices?
Mediscope Manufacturing, Inc.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA requirements before commercial distribution.
Why are Mediscope Manufacturing, Inc.’s devices authorised via the 510(k) pathway?
The 510(k) pathway is used for Class II devices like those produced by Mediscope Manufacturing, Inc. because it provides a streamlined process to demonstrate that a new device is substantially equivalent to an existing, legally marketed device (the predicate). This pathway ensures that the device meets FDA safety and performance standards without requiring the more stringent premarket approval (PMA) process, which is reserved for higher-risk Class III devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (16297)
Page 5 of 326| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medi | CFMS2238 | FDA UDI | Class I | Active |
| Medi | AC36155 | FDA UDI | Class II | Active |
| Medi | 2Y01818 | FDA UDI | Class II | Active |
| Medi | 42N95 | FDA UDI | Class II | Active |
| Medi | 44N52 | FDA UDI | Class II | Active |
| Medi | 44X83 | FDA UDI | Class II | Active |
| Medi | KL11515 | FDA UDI | Class I | Active |
| Medi | D240S937 | FDA UDI | Class II | Active |
| Medi | 473S52 | FDA UDI | Class II | Active |
| Medi | CFAK2156 | FDA UDI | Class I | Active |
| Medi | 2Y11504 | FDA UDI | Class II | Unknown |
| Medi | 48754 | FDA UDI | Class II | Active |
| Medi | KHER1520S-MA | FDA UDI | Class II | Unknown |
| Medi | CJF510R0 | FDA UDI | Class I | Active |
| Medi | CRK1H004 | FDA UDI | Class I | Active |
| Medi | 2Y20802 | FDA UDI | Class II | Unknown |
| Medi | AT26103 | FDA UDI | Class II | Active |
| Medi | AT23114 | FDA UDI | Class II | Unknown |
| Medi | 42T54 | FDA UDI | Class II | Active |
| Medi | 43X95 | FDA UDI | Class II | Active |
| Medi | CJF33504 | FDA UDI | Class I | Active |
| Medi | AT14205 | FDA UDI | Class II | Unknown |
| Medi | PIA0640 | FDA UDI | Class I | Active |
| Medi | 456S83 | FDA UDI | Class II | Active |
| Medi | 46792 | FDA UDI | Class II | Active |
| Medi | 44E54 | FDA UDI | Class II | Active |
| Medi | 3X40121 | FDA UDI | Class II | Active |
| Medi | 190S05 | FDA UDI | Class II | Active |
| Medi | 2Y11801 | FDA UDI | Class II | Unknown |
| Medi | CFMK1153 | FDA UDI | Class I | Active |
| Medi | 458S81 | FDA UDI | Class II | Active |
| Medi | 185S52 | FDA UDI | Class II | Active |
| Medi | 402S01 | FDA UDI | Class II | Active |
| Medi | S240276 | FDA UDI | Class II | Active |
| Medi | 45815 | FDA UDI | Class II | Active |
| Medi | 49152 | FDA UDI | Class II | Active |
| Medi | 20656 | FDA UDI | Class II | Active |
| Medi | 51X94 | FDA UDI | Class II | Active |
| Medi | 50X85 | FDA UDI | Class II | Active |
| Medi | AC362S11 | FDA UDI | Class II | Active |
| Medi | 49202 | FDA UDI | Class II | Active |
| Medi | 42625 | FDA UDI | Class II | Unknown |
| Medi | 497S07 | FDA UDI | Class II | Active |
| Medi | CFAK22M9 | FDA UDI | Class I | Active |
| Medi | 43533 | FDA UDI | Class II | Unknown |
| Medi | 20253 | FDA UDI | Class II | Active |
| Medi | 2Z11811 | FDA UDI | Class II | Unknown |
| Medi | 48293 | FDA UDI | Class II | Active |
| Medi | RKIT5002 | FDA UDI | Class I | Active |
| Medi | 44837 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 11, 2006 | Z-0759-2007 | — | terminated | Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications. |