Identity
- Trade Name
- Pneumo-Matic FDA UDI
- Generic Name
- Simple pneumoperitoneum needle FDA UDI
- Device Name
- 14 Gauge Insufflation Needle FDA UDI
- Model / Reference
- 900-210 FDA UDI
- Description
- 14 Gauge Insufflation Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937003673 FDA UDI
- 510(k) Number
- K970788 FDA UDI
- FDA Product Code
- FHO FDA UDI
- GMDN Term
- Simple pneumoperitoneum needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDI
Category: Simple pneumoperitoneum needle
Pneumo-Matic by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Simple pneumoperitoneum needle.
- Cutting introducer cannula for Veress- — Pajunk GmbH Medizintechnologie · Class II
- Cutting introducer cannula for Veress- — Pajunk GmbH Medizintechnologie · Class II
- Pneumo-Matic — CooperSurgical, Inc. · Class II
Cleared under the same submission
K970788 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI b50f27b2-5b84-4228-85e4-7c3ce3ade41b 35 fields · synced Jun 9, 2026