NEEDLE DRIVER— 510(k) K780255

Substantially Equivalent

Scanlan Intl., Inc.

FDA 510(k) clearance K780255 for NEEDLE DRIVER, Substantially Equivalent on 1978-04-18. Applicant: Scanlan Intl., Inc.. Device class: 1.

Clearance details

Applicant: Scanlan Intl., Inc.
Product code: Code GFC
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1978-02-16
Decision date: 1978-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GFC

K781450 — DRIVERS1978-09-27

More clearances from Scanlan Intl., Inc.

K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM1996-04-26
K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER1994-12-05
K911184 — SCANLAN/TAHERI VALVULOTOME1992-02-18
K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER1987-01-12
K864920 — SCANLAN (TM) INSTRUMENT TRAY1987-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.