SURGIFLATOR 20— 510(k) K950035

Name: FDA 510(k) clearance K950035
Creator: U.S. Food and Drug Administration
Published: 1996-02-12

Substantially Equivalent

W.O.M. GmbH

FDA 510(k) clearance K950035 for SURGIFLATOR 20, Substantially Equivalent on 1996-02-12. Applicant: W.O.M. GmbH. Device class: 2.

Clearance details

Applicant: W.O.M. GmbH
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1995-01-04
Decision date: 1996-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIF

view all

K260209 — ENDOFLATOR+; Smart Smoke Evacuation2026-08-19
K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)2026-06-25
K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

More clearances from W.O.M. GmbH

view all

K922632 — WOM HYSTEROFLATOR OP1994-03-25
K921086 — WOM LAPAROFLATOR ELECTRONIC1992-04-07

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.