Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US
Westmark, Sterile Packing Systems, Inc. (Sps) appears in FDA device records in Grand Rapids, MI. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Westmark, Sterile Packing Systems, Inc. (Sps) between 1988 and 1990. The busiest year on record is 1990, with 21. The most recent is 1990, with 21.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 21 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896800 | IRRIGATION TRAY | KYZ | Unknown | |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | CAZ | Substantially Equivalent | |
| K896559 | INFANT FEEDING TUBE | FPD | Substantially Equivalent | |
| K896794 | SPECIMEN CONTAINER | LIO | Substantially Equivalent | |
| K896806 | CATHETER PLUG/PROTECTOR | KNY | Substantially Equivalent | |
| K896798 | TRACHEOSTOMY TRAY | BTO | Substantially Equivalent | |
| K896797 | SUCTION CATHETER KIT | BSY | Substantially Equivalent | |
| K896215 | MERCY HIP/KNEE PACK | KKX | Substantially Equivalent | |
| K896804 | MANIFOLD | GCX | Substantially Equivalent | |
| K896563 | TUBING CONNECTORS | GCX | Substantially Equivalent | |
| K896562 | STOPCOCK | GCX | Substantially Equivalent | |
| K896558 | YANKAUER SUCTION TUBE-RIGID TYPE | GCX | Substantially Equivalent | |
| K896557 | YANKAUER SUCTION TUBE-FLEXIBLE TYPE | GCX | Substantially Equivalent | |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | GCX | Substantially Equivalent | |
| K896561 | EXTENSION SET | FPA | Substantially Equivalent | |
| K896212 | URETHRAL CATHETERIZATION TRAYS | FCM | Unknown | |
| K896560 | MUCOUS TRAP | BSY | Substantially Equivalent | |
| K896213 | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET | KOD | Substantially Equivalent | |
| K896211 | CYSTOSCOPY/IRRIGATION SET | KOD | Substantially Equivalent | |
| K896210 | GASTRIC SUMP TUBE | KNT | Substantially Equivalent | |
| K896208 | CYSTO PUMP DRAINAGE BAG | KOD | Substantially Equivalent | |
| K896803 | CLOSED WOUND RESERVOIR | GCY | Substantially Equivalent | |
| K896802 | MAGNET PAD | LXG | Substantially Equivalent | |
| K896801 | LAP SPONGE | EFQ | Substantially Equivalent | |
| K896792 | SURGICAL SKIN MARKER | FZZ | Substantially Equivalent | |
| K883472 | CLOSED WOUND SUCTION DEVICE | GCY | Substantially Equivalent | |
| K883474 | THORACIC CATHETERS | GBX | Substantially Equivalent | |
| K883473 | SURGICAL CONNECTING TUBES | GAZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- CAZAnesthesia Conduction Kit
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- GBXCatheter, Irrigation
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- LIODevice, Specimen Collection
- KKXDrape, Surgical, Antimicrobial
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- EFQGauze/Sponge, Internal
- FZZMarker, Skin
- FPASet, Administration, Intravascular
- KYZSyringe, Irrigating (Non Dental)
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- FPDTube, Feeding
- BTOTube, Tracheostomy (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain