Afterloading Gynecological Applicator
by Esi
510(k) K813230
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813230 | Date29 Dec 1981 | StatusActive |
Official records
- FDA 510(k) database K813230
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IWJ
- Device class
- Class I
- Regulation
- 21 CFR Part 892.5650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 10 Nov 2026
Afterloading Gynecological Applicator is a Class I device; the manufacturer on record is Esi. FDA lists it under the product name "System, Applicator, Radionuclide, Manual". The registry lists FDA 510(k) clearance K813230.
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