Thoracoscope/Laparoscope

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K931954 ↗

FDA Product Code

GCM

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Surgical Technologies, Inc. →

• What is the THORACOSCOPE/LAPAROSCOPE used for?

  This rigid endoscope is designed for visual examination of internal body cavities, specifically intended for use in gastroenterology and urology specialties to allow clinicians to view anatomical structures during diagnostic or procedural interventions.

• How was the THORACOSCOPE/LAPAROSCOPE cleared for market?

  The device received FDA 510(k) clearance under submission K931954 on November 2, 1993, based on a determination of substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under regulation 876.1500.

• Who manufactures the THORACOSCOPE/LAPAROSCOPE and where are they located?

  The THORACOSCOPE/LAPAROSCOPE is manufactured by Surgical Technologies, Inc., located at 4715 NW 157th St., Suite 212, Miami Lakes, FL 33014, United States, as indicated in the device’s registration and clearance documentation.