ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI— 510(k) K932115
Substantially EquivalentBlairden Precision Instruments, Inc.
FDA 510(k) clearance K932115 for ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI, Substantially Equivalent on 1994-06-24. Applicant: Blairden Precision Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Blairden Precision Instruments, Inc.
- 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
- Lenexa, KS, US
Recent devices under product code LKF
view allMore clearances from Blairden Precision Instruments, Inc.
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 K932115
K-number listed on FDA's recall record- Z-0439-2013 — Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
- Z-0440-2013 — Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932115.
Data sourced from openFDA. This site is unofficial and independent of the FDA.