Monoscopy Brand Trocar Reducer Set

No FDA recalls on record, checked 22 Oct 2026.

Full name

Monoscopy(Tm) Brand, Trocar Reducer Set

510(k) Number

K902563 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Monoscopy Brand 5mm Lock Trocar Sleeve, Modified

  Class II

  FDA 510(k) K912980 Active Cleared 26 Jul 1991

• Multaport Cannula Reducer and Accessories

  Class II

  FDA 510(k) K981941 Active Cleared 29 Jul 1998

• Multapump Disposable Pump Head and Accessories

  Class II

  FDA 510(k) K981940 Active Cleared 25 Sep 1998

• Dexide Insufflation Tubing with Filter

  Class II

  FDA 510(k) K944509 Active Cleared 7 Feb 1995

• Distendable Palpation Probe

  Class II

  FDA 510(k) K912343 Active Cleared 18 Jun 1991

• Dexide Laparoscopic Accessories

  Class II

  FDA 510(k) K923845 Active Cleared 25 Nov 1992

See all devices from Dexide, Inc. →

• What is the primary purpose of the Monoscopy Brand Trocar Reducer Set in surgical procedures?

  The Monoscopy Brand Trocar Reducer Set is designed to reduce the diameter of a trocar sleeve, enabling smaller port entry during laparoscopic procedures. This allows for minimally invasive surgical techniques while maintaining the functionality of the trocar, particularly in gynecologic and obstetric settings.

• Is the Monoscopy Brand Trocar Reducer Set intended for single-use or reusable applications?

  The Monoscopy Brand Trocar Reducer Set is explicitly supplied as a single-use device, meaning it is intended for one-time use only and should not be reused after a single procedure.

• What regulatory pathway was followed for FDA clearance of this device?

  The Monoscopy Brand Trocar Reducer Set received FDA clearance through the 510(k) process, specifically under the traditional review pathway. It was determined to be substantially equivalent to a predicate device and is classified under the category of Laparoscopes, Gynecologic (and Accessories). The clearance number is K902563.

• Are there any specific storage instructions provided for the Monoscopy Brand Trocar Reducer Set?

  The available data does not include detailed storage conditions for the Monoscopy Brand Trocar Reducer Set. It is recommended to follow manufacturer guidelines or best practices for single-use surgical devices until specific instructions are provided.