HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR— 510(k) K011657
Substantially EquivalentMick Radio-Nuclear Instruments, Inc.
FDA 510(k) clearance K011657 for HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR, Substantially Equivalent on 2001-08-27. Applicant: Mick Radio-Nuclear Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Product code
- Code JAQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mt. Vernon, NY, US
Recent devices under product code JAQ
view allMore clearances from Mick Radio-Nuclear Instruments, Inc.
view all- K230155 — Mick Valencia Applicator Set
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- K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template
- K142597 — Vienna System
- K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
Recalls naming K011657
K-number listed on FDA's recall record- Z-0759-2013 — Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
- Z-0760-2013 — Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011657.
Data sourced from openFDA. This site is unofficial and independent of the FDA.