Novare Surgical Systems, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Novare Surgical Systems, Inc.” (first 2000, latest 2007), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 6 | 6 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
Review panels
Most recent Novare Surgical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072715 | REALHAND HIGH DEXTERITY INSTRUMENTS | GCJ | 2007-10-16 | 21 |
| K071488 | REALHAND HIGH DEXTERITY (HD) INSTRUMENTS | GCJ | 2007-06-29 | 30 |
| K043541 | ENDOLINK TRUE MOVEMENT SYSTEM | GCJ | 2005-03-10 | 78 |
| K032589 | ENCLOSE II ANASTOMOSIS ASSIST DEVICE | DXC | 2003-09-05 | 14 |
| K023682 | ENCLOSE ANASTOMOSIS ASSIST DEVICE | DXC | 2003-01-16 | 76 |
| K010727 | FLEXLINE CLAMP | DXC | 2002-08-09 | 515 |
| K010694 | INCLUDER CLAMP | DXC | 2002-02-11 | 340 |
| K992980 | ENGAGE JAW INSERTS | DXC | 2000-06-08 | 279 |
| K000098 | SOFTLINE SPRING CLIP | DXC | 2000-04-12 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Novare Surgical Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Novare Surgical Systems, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Novare Surgical Systems, Inc.” (first 2000, latest 2007), across 2 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 Novare Surgical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novare Surgical Systems, Inc. is 78 days.
Which FDA product codes appear under Novare Surgical Systems, Inc.?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 6); GCJ (Laparoscope, General & Plastic Surgery, 3).
Next steps
- See all 9 Novare Surgical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXC, Novare Surgical Systems, 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.