7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7— 510(k) K851750

Clearance details

Applicant

Artiberia

Product code

Code GDZ

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

1985-04-25

Decision date

1985-06-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Antonio, TX, US

• K091462 — SPECTRA MEDICAL SAFETY SCAPEL2009-12-15
• K890242 — SCALPEL HANDLE1989-01-27
• K884512 — BEAVER(R) HANDLE1988-11-17
• K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE1986-10-24
• K863808 — THE S. CORDERO STYLUS1986-10-14

• K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B1985-08-29
• K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF1985-07-09
• K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES1985-07-02
• K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS1985-07-02
• K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS1985-07-02

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →