Surgicot, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Surgicot, Inc.” (first 1977, latest 1997), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 5 | 5 |
| FRG | Wrap, Sterilization | 5 | 5 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| BYP | Mouthpiece, Breathing | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 1 | 1 |
| FZZ | Marker, Skin | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
Review panels
- General Hospital (11)
- Anesthesiology (4)
- General and Plastic Surgery (2)
- Ophthalmic (1)
- Physical Medicine (1)
Most recent Surgicot, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | FRG | 1997-03-11 | 252 |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | FLG | 1994-04-13 | 401 |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | FRC | 1986-12-17 | 125 |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | FRC | 1986-07-17 | 206 |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | FRC | 1986-05-27 | 190 |
| K854902 | SURGICOT STEAM TEST PACK | FRC | 1986-05-20 | 162 |
| K840541 | NEURO SPONGE | GDY | 1984-04-23 | 75 |
| K840471 | EYE SPEAR | HOZ | 1984-03-16 | 42 |
| K840470 | SURGISCRIBE MARKING PEN | FZZ | 1984-03-12 | 38 |
| K830739 | PRO-GUARD | FRG | 1983-03-29 | 21 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgicot, 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 Surgicot, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Surgicot, Inc.” (first 1977, latest 1997), across 10 product codes in 5 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 Surgicot, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgicot, Inc. is 42 days.
Which FDA product codes appear under Surgicot, Inc.?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 5); FRG (Wrap, Sterilization, 5); BZA (Connector, Airway (Extension), 2).
Next steps
- See all 19 Surgicot, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRC, Surgicot, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.