GUILLOTINE BLADE— 510(k) K831772

Name: FDA 510(k) clearance K831772
Creator: U.S. Food and Drug Administration
Published: 1983-07-07

Substantially Equivalent

Ortho Pared Instruments, Inc.

FDA 510(k) clearance K831772 for GUILLOTINE BLADE, Substantially Equivalent on 1983-07-07. Applicant: Ortho Pared Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Ortho Pared Instruments, Inc.
Product code: Code HTZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1983-06-02
Decision date: 1983-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTZ

view all

K933933 — CEBOPLANE1994-04-15
K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH1994-01-07
K870882 — 45 DEGREE SHAVER1987-03-23
K853678 — KAMBIN SPINAL INSTRUMENT SET1985-09-24
K850423 — CONCEPT SUCTION SLEEVE1985-03-14

More clearances from Ortho Pared Instruments, Inc.

view all

K820225 — MENISCUS EXTRACTOR1982-02-04
K820226 — UNIVERSALL DRILL GUIDE1982-02-04
K812566 — UNIVERSAL SUTURE PASSER1981-11-10

Adverse events under product code HTZ

product code HTZ

Malfunction: 1,133
Total: 1,133

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 →

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