H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005— 510(k) K013972
Substantially EquivalentAckard Laboratories
FDA 510(k) clearance K013972 for H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005, Substantially Equivalent on 2001-12-17. Applicant: Ackard Laboratories. Device class: 2.
Clearance details
- Applicant
- Ackard 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
- Special
- Location
- Cranford, NJ, US
Recent devices under product code LKF
view allMore clearances from Ackard Laboratories
view allAdverse 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 K013972
K-number listed on FDA's recall record- Z-0503-2024 — Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-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: 61-4005
- Z-0504-2024 — CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013972.
Data sourced from openFDA. This site is unofficial and independent of the FDA.