Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

OKN · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OKN
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: GU
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug. For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown