Identity
- Trade Name
- LEISEGANG FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- LM-900 CO2 Cryosurgery System. Contents: 1 Cryogun, replacement O-rings, cleaning plugs and gas scavenging hose. FDA UDI
- Model / Reference
- 50502 FDA UDI
- Description
- LM-900 CO2 Cryosurgery System. Contents: 1 Cryogun, replacement O-rings, cleaning plugs and gas scavenging hose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937009974 FDA UDI
- 510(k) Number
- K854767 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
Leisegang by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K854767 also covers:
- LEISEGANG — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
- Leisegang Cryotip for LM-900 — CooperSurgical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI bf5968ea-e66a-437d-a45e-73c4097df4f6 34 fields · synced Jun 9, 2026