Scanlan Intl., Inc.: FDA clearances and approvals
Scanlan Intl., Inc. has 19 FDA 510(k) clearances (first 1978, latest 1996), across 15 product codes in 6 review panels. Median 510(k) review time: 54 days.
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 |
|---|---|---|---|
| HRQ | Hemostat | 3 | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 2 | 2 |
| DWX | Stripper, Artery, Intraluminal | 1 | 1 |
| FMP | Protector, Skin Pressure | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FZZ | Marker, Skin | 1 | 1 |
| GAB | Needle, Suturing, Disposable | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GFC | Driver, Surgical, Pin | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
Plus 5 more product codes.
Review panels
- General and Plastic Surgery (8)
- Cardiovascular (5)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Scanlan Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960372 | SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM | HCH | 1996-04-26 | 91 |
| K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER | GCJ | 1994-12-05 | 27 |
| K911184 | SCANLAN/TAHERI VALVULOTOME | MGZ | 1992-02-18 | 337 |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | FSM | 1987-01-12 | 27 |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | KPK | 1987-01-12 | 27 |
| K851825 | SCANLAN TUNNELER, SHEATH & TIP | DWS | 1985-07-12 | 77 |
| K841521 | SCANLAN ENDARSECTOR | DWX | 1984-08-03 | 113 |
| K841513 | SCANLAN ATRAUM INSTRUMENT JAW COVER | — | 1984-07-06 | 85 |
| K841085 | SCANLAN COLORMARK SKIN MARKER | FZZ | 1984-06-11 | 90 |
| K841515 | SCANLAN VASCU-STATT II | HRG | 1984-06-05 | 54 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scanlan Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Scanlan Intl., Inc. have?
Scanlan Intl., Inc. has 19 FDA 510(k) clearances (first 1978, latest 1996), across 15 product codes in 6 review panels.
How long does FDA take to clear Scanlan Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Scanlan Intl., Inc.'s cleared 510(k)s is 54 days.
What devices does Scanlan Intl., Inc. make?
Its most frequent FDA product codes are HRQ (Hemostat, 3); DWS (Instruments, Surgical, Cardiovascular, 2); DWX (Stripper, Artery, Intraluminal, 1).
Has Scanlan Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Scanlan Intl., Inc. Related entities may recall under other names.
Next steps
- See all 19 Scanlan Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRQ, Scanlan Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.