EXTEMP-V— 510(k) K771759

Name: FDA 510(k) clearance K771759
Creator: U.S. Food and Drug Administration
Published: 1977-09-28

Substantially Equivalent

Pharmaco, Inc.

FDA 510(k) clearance K771759 for EXTEMP-V, Substantially Equivalent on 1977-09-28. Applicant: Pharmaco, Inc.. Device class: 1.

Clearance details

Applicant: Pharmaco, Inc.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-09-19
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAA

view all

K223625 — CapnoSpot Pneumothorax Decompression Indicator2023-03-28
K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT2011-06-15
K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE2001-11-16
K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES2000-03-01
K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX1998-12-11

More clearances from Pharmaco, Inc.

view all

K771760 — EXTEMP1977-09-28

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.