Company ยท US
Surgical Appliance Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2012. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FQL | Stocking, Medical Support (For General Medical Purposes) | 2 |
| IPY | Orthosis, Lumbo-Sacral | 2 |
| ITQ | Joint, Knee, External Brace | 2 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 1 |
| IPT | Orthosis, Thoracic | 1 |
| IQE | Orthosis, Lumbar | 1 |
| IQI | Orthosis, Limb Brace | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2012 | K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET Surgical Appliance Industries, Inc. | DWL |
| Jun 24, 1982 | K821682 | TRUNCAL ORTHOSIS Surgical Appliance Industries, Inc. | IQE |
| Jan 18, 1982 | K813416 | EXTERNAL BREAST PROSTHESIS Surgical Appliance Industries, Inc. | GBI |
| Sep 14, 1981 | K812423 | NEOPRENE KNEE SUPPORT Surgical Appliance Industries, Inc. | ITQ |
| Sep 14, 1981 | K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS Surgical Appliance Industries, Inc. | IPY |
| Sep 14, 1981 | K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O Surgical Appliance Industries, Inc. | IPT |
| Jun 25, 1981 | K811690 | ANKLE-FOOT CAST/SPLINT Surgical Appliance Industries, Inc. | IQI |
| Jun 25, 1981 | K811689 | CYLINDER KNEE CAST/SPLINT Surgical Appliance Industries, Inc. | ITQ |
| Jun 16, 1981 | K811494 | LUMBO-SACRAL FLEXION ORTHOSIS Surgical Appliance Industries, Inc. | IPY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Surgical Appliance Industries Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI, Cincinnati, OH 45209
Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose v Terminated |
FQL | None listed |
| Jan 11, 2012 | Surgical Appliance Industries Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of SAI, Cincinnati, OH 45209
Product Usag Terminated |
FQL | None listed |