INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER— 510(k) K970492
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K970492 for INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER, Substantially Equivalent on 1997-04-09. Applicant: Ackrad Laboratories. Device class: 2.
Clearance details
- Applicant
- Ackrad Laboratories
- Product code
- Code LKF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cranford, NJ, US
Recent devices under product code LKF
view allMore clearances from Ackrad Laboratories
view all- K021272 — SIB CATHETER, MODEL 61-7005
- K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
- K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
- K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
- K940176 — ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
Adverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K970492
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970492.
Data sourced from openFDA. This site is unofficial and independent of the FDA.