Identity
- Trade Name
- Salman FES Stent FDA UDI
- Generic Name
- Paranasal sinus spacer FDA UDI
- Model / Reference
- SS2000 FDA UDI
Identifiers
- Catalog Number
- SS2000 FDA UDI
- Primary DI / UDI-DI
- EBESSS20000 FDA UDI
- 510(k) Number
- K922902 FDA UDI
- FDA Product Code
- KAM FDA UDI
- GMDN Term
- Paranasal sinus spacer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
MR Safe FDA UDI
Category: Paranasal sinus spacer
Salman FES Stent by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Paranasal sinus spacer.
- Propel Mini — Intersect Ent. · Class III
- Propel Mini Straight Delivery System (SDS) Single Unit — Intersect Ent. · Class III
- Propel — Intersect Ent. · Class III
- PROPEL Mini Sinus Implant with Straight Delivery System — Intersect Ent. · Class III
- Propel Contour — Intersect Ent. · Class III
- Salman FES Stent — Boston Medical Products, Inc. · Class I
Cleared under the same submission
K922902 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 I | Pending data |
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Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 14d53864-efa7-48c0-a0e6-1a696dff8cfa 36 fields · synced Jun 9, 2026