G.E.V. DISPOSABLE SCALPELS— 510(k) K822893

Substantially Equivalent

Ascep, Inc.

FDA 510(k) clearance K822893 for G.E.V. DISPOSABLE SCALPELS, Substantially Equivalent on 1982-10-22. Applicant: Ascep, Inc.. Device class: 1.

Clearance details

Applicant: Ascep, Inc.
Product code: Code GDX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1982-09-28
Decision date: 1982-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDX

K923689 — SURGISTAR BLADES1992-09-09
K921167 — ULTRABLADE1992-07-30
K914086 — ICAN CYLINDRICAL SPONGES1991-10-09
K904505 — CCI CORNEAL SCARIFIER1991-04-23
K905380 — 1-CUT ACL GRAFT KNIFE1990-12-13

More clearances from Ascep, Inc.

K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS1983-04-12
K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS1981-01-26
K802726 — INSTRUMENTS NONSTERILE & STERILE1980-11-19
K791886 — I.V. CARE KIT1979-10-26
K791885 — I.V. START SET1979-10-22

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