SCALPEL HANDLE— 510(k) K890242

Clearance details

Applicant

Kinetic Medical Products

Product code

Code GDZ

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

1989-01-18

Decision date

1989-01-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Erie, PA, US

• K091462 — SPECTRA MEDICAL SAFETY SCAPEL2009-12-15
• K884512 — BEAVER(R) HANDLE1988-11-17
• K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE1986-10-24
• K863808 — THE S. CORDERO STYLUS1986-10-14
• K863212 — KEISEI HANDLES FOR SURGICAL BLADES1986-09-02

• K890385 — MIDWIFERY/OBSTETRICAL FORCEPS1989-03-01
• K890376 — VAGINAL SPECULUM1989-02-27
• K890380 — CERVICAL BIOPSY FORCEPS1989-02-27
• K890382 — COMPRESSION FORCEPS1989-02-27
• K890387 — MALLEABLE PLACENTA CURETTE1989-02-27

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 →