Pillar Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pillar Surgical, Inc.” (first 1995, latest 2000), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 136 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 | 0 | — |
| 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
| MIB | Elastomer, Silicone Block | 1 | 1 |
| MIC | Implant, Muscle, Pectoralis | 1 | 1 |
Review panels
Most recent Pillar Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002633 | SILMAX PECTORAL IMPLANT | MIC | 2000-11-21 | 90 |
| K002629 | SILMAX CONTOUR CARVING BLOCK IMPLANT | JOF | 2000-11-20 | 89 |
| K992242 | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | FZE | 1999-11-22 | 143 |
| K992240 | PILLAR MALAR IMPLANT | LZK | 1999-11-22 | 143 |
| K992239 | PILLAR CHIN IMPLANT | FWP | 1999-11-22 | 143 |
| K991970 | SCAREASE SHEETS & SCAREASE GEL | MDA | 1999-10-25 | 136 |
| K954382 | PROLASTIC SHEETING | MIB | 1995-11-29 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Pillar Surgical, Inc..
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.
- Pillar Technology, Inc. (6 510(k)s)
- Pillar Biosciences (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pillar Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Pillar Surgical, Inc.” (first 1995, latest 2000), across 7 product codes in 2 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 Pillar Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pillar Surgical, Inc. is 136 days.
Which FDA product codes appear under Pillar Surgical, Inc.?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 1); FZE (Prosthesis, Nose, Internal, 1); JOF (Polymer, Ent Synthetic, Porous Polyethylene, 1).
Next steps
- See all 7 Pillar Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWP, Pillar Surgical, 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.