Spembly 9000 & 9300

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K802063 ↗

FDA Product Code

GZJ

FDA applicant

Spembly Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Selector Ultrasonic Surgical Aspirator

  Unclassified

  FDA 510(k) K901974 Active Cleared 5 Sep 1990

• Cryoprobes Mc-1400-Cryosurg-Console

  Class II

  FDA 510(k) K832385 Active Cleared 12 Sep 1983

• Obstetric Pulsar Two Channel Tens

  Class II

  FDA 510(k) K840497 Active Cleared 16 Apr 1984

• Cryomedics Neurostat

  Class II

  FDA 510(k) K831963 Active Cleared 12 Aug 1983

• Various Cardiac Cryoprobes Having Dia. & Cos. Diff

  Class II

  FDA 510(k) K874367 Active Cleared 4 Jan 1988

• Neurostat, Lloyd

  Class II

  FDA 510(k) K781302 Active Cleared 15 Aug 1978

See all devices from Spembly Medical, Ltd. →

• Are the Spembly 9000 & 9300 devices intended for single-use or can they be reused in multiple procedures?

  The Spembly 9000 & 9300 are explicitly described as reusable medical instruments, meaning they are designed for repeated use after proper cleaning, sterilization, and maintenance between procedures. This classification aligns with their regulatory submission under the FDA’s 510(k) pathway, where reusable electrosurgical tools are standard.

• What types of neurosurgical procedures are these devices primarily used for?

  The Spembly 9000 & 9300 are specifically designed for brain tissue coagulation and cutting during neurosurgical procedures. Their high-frequency electrical current enables precise manipulation of neurological tissue, making them suitable for interventions within the brain. The device’s intended use is reflected in its FDA clearance under the Neurology Advisory Committee review.

• How are these devices supplied, and do they come in multiple sizes or models?

  The data provided does not specify individual sizes or models beyond the 9000 and 9300 series, which are two distinct electrosurgical instruments. Both are supplied as reusable instruments, but exact variations (e.g., blade shapes, tip designs, or handle configurations) are not detailed in the regulatory submission. For precise sizing or model-specific features, consult the manufacturer’s technical documentation.

• Are there any special storage requirements for these reusable electrosurgical devices?

  While the regulatory data does not explicitly outline storage instructions, reusable electrosurgical instruments like the Spembly 9000 & 9300 typically require clean, dry, and protected environments to prevent damage or contamination. Proper storage should follow manufacturer guidelines for electrosurgical tools, including avoiding exposure to moisture, extreme temperatures, or physical stress. Always refer to Spembly Medical’s operational manual for device-specific storage recommendations.

• What was the regulatory pathway and timeline for FDA clearance of these devices?

  The Spembly 9000 & 9300 were cleared via the FDA’s 510(k) pathway, determined to be substantially equivalent to a predicate device. The submission was received on August 26, 1980, and reviewed by the Neurology Advisory Committee (NE), leading to clearance on October 3, 1980. The clearance type was Traditional, and the product code assigned was GZJ, categorizing them under electrosurgical instruments for neurosurgery.