Identity
- Trade Name
- Balloon Applicator FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Model / Reference
- MAJ-675 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170061912 FDA UDI
- 510(k) Number
- K093395 FDA UDI
- FDA Product Code
- IYN FDA UDINWB FDA UDIODG FDA UDIITX FDA UDIIYO FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI876.1500 FDA UDI892.1570 FDA UDI892.1560 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Balloon Applicator by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument assist arm system, manually-adjusted.
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- Smeed Technologies — SMEED TECHNOLOGIES LLC · Class I
- Flexarm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- Flexarm Plus Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- Flexarm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · Class II
- StrongArm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
Cleared under the same submission
K093395 also covers:
- Air/Water Channel Cleaning Brush — Olympus Medical Systems Corporation
- Balloon Applicator — Olympus Medical Systems Corporation
- CLEANING ADAPTER FOR INSTRUMENT CHANNELPORT — Olympus Medical Systems Corporation
- Channel Plug — Olympus Medical Systems Corporation
- Channel Plug — Olympus Medical Systems Corporation
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI b7f1cd60-664e-4c99-b4f6-b93c9ba8cb88 34 fields · synced May 30, 2026