DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET— 510(k) K935503

Name: FDA 510(k) clearance K935503
Creator: U.S. Food and Drug Administration
Published: 1994-03-07

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K935503 for DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET, Substantially Equivalent on 1994-03-07. Applicant: Davol, Inc.. Device class: 2.

Clearance details

Applicant: Davol, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1993-11-16
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIF

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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

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K031213 — AQUASENS FLUID MONITORING SYSTEM2003-04-30
K030307 — DAVOL ARTHROVENT OUTFLOW TUBING2003-02-13
K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,00102052001-01-22

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.