Company ยท US
Westmark, Sterile Packing Systems, Inc. (Sps)
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1990. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 6 |
| KOD | Catheter, Urological | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| CAZ | Anesthesia Conduction Kit | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FPD | Tube, Feeding | 1 |
| FZZ | Marker, Skin | 1 |
| GAZ | Tubing, Noninvasive | 1 |
| GBX | Catheter, Irrigation | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 |
| LIO | Device, Specimen Collection | 1 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 1990 | K896800 | IRRIGATION TRAY Westmark, Sterile Packing Systems, Inc. (Sps) | KYZ |
| Apr 23, 1990 | K896799 | PARACERVICAL/PUDENDAL TRAYS Westmark, Sterile Packing Systems, Inc. (Sps) | CAZ |
| Mar 13, 1990 | K896559 | INFANT FEEDING TUBE Westmark, Sterile Packing Systems, Inc. (Sps) | FPD |
| Mar 1, 1990 | K896794 | SPECIMEN CONTAINER Westmark, Sterile Packing Systems, Inc. (Sps) | LIO |
| Feb 26, 1990 | K896806 | CATHETER PLUG/PROTECTOR Westmark, Sterile Packing Systems, Inc. (Sps) | KNY |
| Feb 22, 1990 | K896798 | TRACHEOSTOMY TRAY Westmark, Sterile Packing Systems, Inc. (Sps) | BTO |
| Feb 16, 1990 | K896797 | SUCTION CATHETER KIT Westmark, Sterile Packing Systems, Inc. (Sps) | BSY |
| Feb 13, 1990 | K896215 | MERCY HIP/KNEE PACK Westmark, Sterile Packing Systems, Inc. (Sps) | KKX |
| Feb 8, 1990 | K896804 | MANIFOLD Westmark, Sterile Packing Systems, Inc. (Sps) | GCX |
| Feb 6, 1990 | K896563 | TUBING CONNECTORS Westmark, Sterile Packing Systems, Inc. (Sps) | GCX |
| Feb 6, 1990 | K896562 | STOPCOCK Westmark, Sterile Packing Systems, Inc. (Sps) | GCX |
| Feb 6, 1990 | K896558 | YANKAUER SUCTION TUBE-RIGID TYPE Westmark, Sterile Packing Systems, Inc. (Sps) | GCX |
| Feb 6, 1990 | K896557 | YANKAUER SUCTION TUBE-FLEXIBLE TYPE Westmark, Sterile Packing Systems, Inc. (Sps) | GCX |
| Feb 6, 1990 | K896556 | UNIVERSAL POOLE SUCTION TUBE Westmark, Sterile Packing Systems, Inc. (Sps) | GCX |
| Feb 1, 1990 | K896561 | EXTENSION SET Westmark, Sterile Packing Systems, Inc. (Sps) | FPA |
| Jan 24, 1990 | K896212 | URETHRAL CATHETERIZATION TRAYS Westmark, Sterile Packing Systems, Inc. (Sps) | FCM |
| Jan 22, 1990 | K896560 | MUCOUS TRAP Westmark, Sterile Packing Systems, Inc. (Sps) | BSY |
| Jan 18, 1990 | K896213 | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET Westmark, Sterile Packing Systems, Inc. (Sps) | KOD |
| Jan 18, 1990 | K896211 | CYSTOSCOPY/IRRIGATION SET Westmark, Sterile Packing Systems, Inc. (Sps) | KOD |
| Jan 18, 1990 | K896210 | GASTRIC SUMP TUBE Westmark, Sterile Packing Systems, Inc. (Sps) | KNT |
| Jan 18, 1990 | K896208 | CYSTO PUMP DRAINAGE BAG Westmark, Sterile Packing Systems, Inc. (Sps) | KOD |
| Dec 27, 1989 | K896803 | CLOSED WOUND RESERVOIR Westmark, Sterile Packing Systems, Inc. (Sps) | GCY |
| Dec 27, 1989 | K896802 | MAGNET PAD Westmark, Sterile Packing Systems, Inc. (Sps) | LXG |
| Dec 27, 1989 | K896801 | LAP SPONGE Westmark, Sterile Packing Systems, Inc. (Sps) | EFQ |
| Dec 27, 1989 | K896792 | SURGICAL SKIN MARKER Westmark, Sterile Packing Systems, Inc. (Sps) | FZZ |
| Oct 18, 1988 | K883472 | CLOSED WOUND SUCTION DEVICE Westmark, Sterile Packing Systems, Inc. (Sps) | GCY |
| Sep 13, 1988 | K883474 | THORACIC CATHETERS Westmark, Sterile Packing Systems, Inc. (Sps) | GBX |
| Aug 25, 1988 | K883473 | SURGICAL CONNECTING TUBES Westmark, Sterile Packing Systems, Inc. (Sps) | GAZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||