Flexible Fixation Device for Gynecological Applicators (GM11001960)
Varian Medical Systems, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Palo Alto
- Advisory committee description
- Radiology
- Address 1
- 3100 Hansen Way
- Statement or summary
- Summary
- Product code
- JAQ
- Zip code
- 94304
- Applicant
- Varian Medical Systems, Inc.
- Decision date
- 2024-05-09
- Decision code
- SESE
- Country code
- US
- Device name
- Flexible Fixation Device for Gynecological Applicators (GM11001960)
- Advisory committee
- RA
- Contact
- Dr. Lynn Allman
- K number
- K240495
- State
- CA
- Date received
- 2024-02-20
- Review advisory committee
- RA
- Postal code
- 94304
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Applicator, Radionuclide, Remote-Controlled
- Medical specialty description
- Radiology
- Regulation number
- 892.5700
- Device class
- 2
- Registration number
- 3008236846, 1417485, 3019543601, 3003660614, 3007200016, 1120804, 1650907, 3015225571, 1000523114, 9610348, 2431392, 3038188187, 2518443, 3016602874, 1422634, 1721504, 2032112, 1219183, 2032338, 3010813819, 9611894, 1222780, 8010168, 1181121, 3012536737, 3034286426, 1644312, 3004111573, 3033589330, 3032638959, 3015232217, 1220477, 2184007, 2246552, 3006950086, 2022435, 1649518, 3009417901, 2029275, 3014246639 +5 more
- FEI number
- 3008236846, 1417485, 3019543601, 3003660614, 3007200016, 1120804, 3015225571, 1000523114, 3003295907, 2431392, 3038188187, 2518443, 3016602874, 1721504, 1219183, 3002806617, 3010813819, 3002807741, 1000306431, 1181121, 1000453845, 3012536737, 3004111573, 3002681132, 1937223, 3033589330, 3032638959, 3015232217, 1000117748, 1220477, 1000514656, 2246552, 3006950086, 2022435, 1000115748, 3001236277, 3009417901, 3003076831, 3014246639, 3000270450 +5 more