Surgical Appliance Industries, Inc.
Cincinnati, OH, US
SURGICAL APPLIANCE INDUSTRIES, INC. appears in FDA device records in Cincinnati, OH. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Surgical Appliance Industries, Inc. between 1981 and 2012. The busiest year on record is 1981, with 6. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 6 |
| 1982 | 2 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | DWL | Substantially Equivalent | |
| K821682 | TRUNCAL ORTHOSIS | IQE | Substantially Equivalent | |
| K813416 | EXTERNAL BREAST PROSTHESIS | GBI | Substantially Equivalent | |
| K812423 | NEOPRENE KNEE SUPPORT | ITQ | Substantially Equivalent | |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | IPY | Substantially Equivalent | |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | IPT | Substantially Equivalent | |
| K811690 | ANKLE-FOOT CAST/SPLINT | IQI | Substantially Equivalent | |
| K811689 | CYLINDER KNEE CAST/SPLINT | ITQ | Substantially Equivalent | |
| K811494 | LUMBO-SACRAL FLEXION ORTHOSIS | IPY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1511629 | 1511629 | SURGICAL APPLIANCE INDUSTRIES, INC. | 3960 ROSSLYN DR., CINCINNATI, OH 45209 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILZAccessories, Traction
- IKXAid, Transfer
- HSTApparatus, Traction, Non-Powered
- ISRBand Or Belt, Pelvic Support
- FQMBandage, Elastic
- FSDBinder, Abdominal
- ITMCage, Knee
- KIACover, Cast
- HSSHalter, Head, Traction
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
- KTDOrthosis, Abdominal
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPXOrthosis, Rib Fracture, Soft
- IPWOrthosis, Sacroiliac, Soft
- IPTOrthosis, Thoracic
- IMEPack, Hot Or Cold, Reusable
- ILISling, Arm
- IQJSplint, Clavicle
- ILGStocking, Elastic
- FQLStocking, Medical Support (For General Medical Purposes)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- EXNSupport, Hernia
- FQJSupport, Scrotal, Therapeutic
- KGXTape And Bandage, Adhesive
- EXMTruss, Umbilical
- HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0392-2012 | 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 veins and swelling. | During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s | Terminated | ||
| Z-0391-2012 | 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 Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling. | During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain