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510(k) K991526

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 by Imagyn Medical Technologies, Inc. — Product Code KXK

K991526 is an FDA 510(k) premarket notification submitted by Imagyn Medical Technologies, Inc. for the device "ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501". The FDA issued a decision of Substantially Equivalent on June 17, 1999. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Imagyn Medical Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1999
Date Received
May 3, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Imagyn Medical Technologies, Inc.

  • K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (September 4, 2003)
  • K012706 — IM2001 PULSE OXIMETER (March 7, 2003)
  • K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (December 3, 2001)
  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K980291 — IMPOWER EXTERNAL VACUUM SYSTEM (March 11, 1998)
  • K974173 — ERECAID SYSTEM/STAY EREC SYSTEM (February 25, 1998)

Other clearances for product code KXK

  • K252296 — OncoPatch (December 5, 2025)
  • K242818 — IsoSphere (July 15, 2025)
  • K223465 — RadianceTx Radionuclide Brachytherapy Source (January 11, 2023)
  • K221539 — GammaTile (November 9, 2022)
  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (May 29, 2020)
  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K190296 — GammaTile (March 13, 2019)
  • K180515 — GammaTile (July 6, 2018)

FDA data resources