THE TULIP MONO-POLAR CAUTERY SPATULA— 510(k) K952973

Name: FDA 510(k) clearance K952973
Creator: U.S. Food and Drug Administration
Published: 1995-09-11

Substantially Equivalent

The Tulip Mfg. Co.

FDA 510(k) clearance K952973 for THE TULIP MONO-POLAR CAUTERY SPATULA, Substantially Equivalent on 1995-09-11. Applicant: The Tulip Mfg. Co.. Device class: 2.

Clearance details

Applicant: The Tulip Mfg. Co.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1995-06-27
Decision date: 1995-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesa, AZ, US

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K952906 — THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK1996-01-22
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K955501 — THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP1996-01-17
K955502 — THE TULIP MONO POLAR ROTATABLE METZ SCISSORS1996-01-17
K952901 — THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR1995-11-14

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.