LEEP REDIKIT— 510(k) K910253
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K910253 for LEEP REDIKIT, Substantially Equivalent on 1991-04-18. Applicant: CooperSurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Code HEE
- Device class
- Class 2
- Regulation
- 21 CFR 884.5100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
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More clearances from CooperSurgical, Inc.
view allRecalls naming K910253
K-number listed on FDA's recall record- Z-0105-2016 — CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
- Z-1053-2013 — LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910253.
Data sourced from openFDA. This site is unofficial and independent of the FDA.