COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES— 510(k) K933768

Name: FDA 510(k) clearance K933768
Creator: U.S. Food and Drug Administration
Published: 1994-06-27

Substantially Equivalent

Mahe-Medizintechnik

FDA 510(k) clearance K933768 for COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES, Substantially Equivalent on 1994-06-27. Applicant: Mahe-Medizintechnik. Device class: 2.

Clearance details

Applicant: Mahe-Medizintechnik
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1993-07-29
Decision date: 1994-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HET

view all

K250939 — SIRIUS Endoscope System (PR-SI-1230)2025-08-29
K243821 — i-Cut2025-04-25
K221642 — SIRIUS Endoscope System2022-12-12
K210116 — Video Endoscopy System, 3D Video Endoscopy System2021-10-13
K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-52021-09-17

More clearances from Mahe-Medizintechnik

view all

K942821 — MAHE INSTRUMENTS1994-11-02
K942819 — TROCAR WITH SHIELD1994-08-23
K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY1994-05-26
K933770 — FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE1994-03-23
K935442 — MAHE INSTRUMENTS1994-03-14

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.