Surgical Appliance Industries, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Surgical Appliance Industries, Inc.” (first 1981, latest 2012), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 20 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 15 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | 2 | 2 |
| ITQ | Joint, Knee, External Brace | 2 | 2 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 | 1 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 1 | 1 |
| IPT | Orthosis, Thoracic | 1 | 1 |
| IQE | Orthosis, Lumbar | 1 | 1 |
| IQI | Orthosis, Limb Brace | 1 | 1 |
Review panels
Most recent Surgical Appliance Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | DWL | 2012-04-27 | 15 |
| K821682 | TRUNCAL ORTHOSIS | IQE | 1982-06-24 | 16 |
| K813416 | EXTERNAL BREAST PROSTHESIS | GBI | 1982-01-18 | 42 |
| K812423 | NEOPRENE KNEE SUPPORT | ITQ | 1981-09-14 | 21 |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | IPY | 1981-09-14 | 21 |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | IPT | 1981-09-14 | 25 |
| K811690 | ANKLE-FOOT CAST/SPLINT | IQI | 1981-06-25 | 10 |
| K811689 | CYLINDER KNEE CAST/SPLINT | ITQ | 1981-06-25 | 10 |
| K811494 | LUMBO-SACRAL FLEXION ORTHOSIS | IPY | 1981-06-16 | 20 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-10-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Appliance Industries, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Surgical Appliance Industries, Inc.” (first 1981, latest 2012), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surgical Appliance Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Appliance Industries, Inc. is 20 days.
Which FDA product codes appear under Surgical Appliance Industries, Inc.?
The most frequent FDA product codes under this applicant name are IPY (Orthosis, Lumbo-Sacral, 2); ITQ (Joint, Knee, External Brace, 2); DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), 1).
Next steps
- See all 9 Surgical Appliance Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPY, Surgical Appliance Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.