CO2 Cystoscopy/Urethroscopy Console

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K800822 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Forceps, Electrosurgical

  Class II

  FDA 510(k) K781109 Active Cleared 14 Sep 1978

• Insufflator, Model G100 & 200

  Class II

  FDA 510(k) K772297 Active Cleared 5 Jan 1978

• Laparoscopy Console Model VIII

  Class II

  FDA 510(k) K772242 Active Cleared 20 Dec 1977

• One Incision Bi-Polar Electro. Forceps

  Class II

  FDA 510(k) K781089 Active Cleared 17 Jul 1978

• 8mm Trocar & Cannual W/Stopcock

  Class II

  FDA 510(k) K771964 Active Cleared 25 Oct 1977

• Scissors, Hook, Electrosurgical

  Class II

  FDA 510(k) K780954 Active Cleared 22 Jun 1978

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