SCALPEL HANDLE #3 SS 410 OR 420— 510(k) K852711

Clearance details

Applicant

The Huxley Instrument Corp.

Product code

Code GDZ

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

1985-06-26

Decision date

1985-07-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Penn Yan, NY, 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

• K852721 — BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 4201985-09-06
• K852993 — BONE RONGEURS1985-08-07
• K853016 — STILLE ANGULAR RONGEUR, 8-3/4 SS 4101985-08-07
• K853015 — SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS4201985-07-29
• K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 4201985-07-26

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 →