H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)— 510(k) K961752
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K961752 for H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607), Substantially Equivalent on 1996-08-08. 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
- K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
- 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 K961752
K-number listed on FDA's recall record- Z-1613-2022 — Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
- Z-0502-2024 — Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961752.
Data sourced from openFDA. This site is unofficial and independent of the FDA.