Identity
- Trade Name
- Speed-Lock FDA UDI
- Generic Name
- Arthroscopic access cannula, reusable FDA UDI
- Device Name
- Syringe Adapter for 4 mm Arthroscope FDA UDI
- Model / Reference
- 0377031900 FDA UDI
- Description
- Syringe Adapter for 4 mm Arthroscope FDA UDI
Identifiers
- Catalog Number
- 377-031-900 FDA UDI
- Primary DI / UDI-DI
- 07613327057805 FDA UDI
- 510(k) Number
- K935237 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Arthroscopic access cannula, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arthroscopic access cannula, reusable
Speed-Lock by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic access cannula, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- INFLOW CANNULA SET — SONTEC INSTRUMENTS, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- INFLOW CANNULA SET — SONTEC INSTRUMENTS, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- OBTURATOR — SONTEC INSTRUMENTS, INC. · Class I
Cleared under the same submission
K935237 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 |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 4368cec2-6cb3-41aa-ad90-f60fe7af220a 36 fields · synced May 30, 2026