Scanlan Intl., Inc.
Mchenry, IL, US
Scanlan Intl., Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Scanlan Intl., Inc. between 1978 and 1996. The busiest year on record is 1984, with 6. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 6 |
| 1985 | 1 |
| 1987 | 2 |
| 1992 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960372 | SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM | HCH | Substantially Equivalent | |
| K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER | GCJ | Substantially Equivalent | |
| K911184 | SCANLAN/TAHERI VALVULOTOME | MGZ | Substantially Equivalent | |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | FSM | Substantially Equivalent | |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | KPK | Substantially Equivalent | |
| K851825 | SCANLAN TUNNELER, SHEATH & TIP | DWS | Substantially Equivalent | |
| K841521 | SCANLAN ENDARSECTOR | DWX | Substantially Equivalent | |
| K841513 | SCANLAN ATRAUM INSTRUMENT JAW COVER | Substantially Equivalent | ||
| K841085 | SCANLAN COLORMARK SKIN MARKER | FZZ | Substantially Equivalent | |
| K841515 | SCANLAN VASCU-STATT II | HRG | Substantially Equivalent | |
| K841514 | SCANLAN VASCU-STATT II APPROXIMATOR | HRQ | Substantially Equivalent | |
| K841086 | SURGICAL INSTRUMENT DEMAGNETIZER | Substantially Equivalent | ||
| K823764 | SCANLAN SINGLE-USE AORTA PUNCH | DWS | Substantially Equivalent | |
| K823694 | VASCU-STATT APPROXIMATOR | HRQ | Substantially Equivalent | |
| K821887 | SCANLAN SUTURE-STATT | HRQ | Substantially Equivalent | |
| K810480 | SCANLAN SUTURE BOOTS | KOC | Substantially Equivalent | |
| K802829 | SCANLAN VASCU-STATT | FMP | Substantially Equivalent | |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | GAB | Substantially Equivalent | |
| K780255 | NEEDLE DRIVER | GFC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- HCHClip, Aneurysm
- GFCDriver, Surgical, Pin
- HRGEngine, Trephine, Accessories, Ac-Powered
- HRQHemostat
- DWSInstruments, Surgical, Cardiovascular
- GCJLaparoscope, General & Plastic Surgery
- KPKMarker, Ostia, Aorto-Saphenous Vein
- FZZMarker, Skin
- GABNeedle, Suturing, Disposable
- FMPProtector, Skin Pressure
- DWXStripper, Artery, Intraluminal
- FSMTray, Surgical, Instrument
- MGZValvulotome
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain