MEDICAM 900 INSUFFLATOR WITH ACCESSORIES— 510(k) K921837

Name: FDA 510(k) clearance K921837
Creator: U.S. Food and Drug Administration
Published: 1993-02-05

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K921837 for MEDICAM 900 INSUFFLATOR WITH ACCESSORIES, Substantially Equivalent on 1993-02-05. Applicant: Kirschner Medical Corp.. Device class: 2.

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1992-04-17
Decision date: 1993-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

Download summary PDF View on FDA.gov ↗

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K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

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K940537 — KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM1995-08-29
K936274 — KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM1995-01-18
K942891 — SUMMIT TOTAL HIP SYSTEM1994-11-02
K941486 — INTEGRITY TOTAL HIP SYSTEM, NON-POROUS1994-09-20
K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED1994-08-05

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.