Cleared Traditional

K932762 - 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (FDA 510(k) Clearance)

Aug 1993
Decision
84d
Days
Class 2
Risk

K932762 is an FDA 510(k) clearance for the 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT. This device is classified as a Endoscope, Battery-powered And Accessories (Class II - Special Controls, product code GCS).

Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on August 31, 1993, 84 days after receiving the submission on June 8, 1993.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K932762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date August 31, 1993
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code GCS — Endoscope, Battery-powered And Accessories
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.1500

Similar Devices — GCS Endoscope, Battery-powered And Accessories

All 8
LAPRASCOPIC GRASPER
K944062 · Instrument Makar, Inc. · Feb 1995
PEANUT WAND, MODIFICATION
K944067 · Ideal Medical, Inc. · Dec 1994
AESCULAP TROCAR INSTRUMENT SET
K933201 · Aesculap, Inc. · Sep 1993
IMC ENDOSCOPIC INSTRUMENT HOLDER
K933371 · Inman Medical Corp. · Aug 1993
LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
K924134 · Leisegang Medical, Inc. · Jul 1993
GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
K931340 · Baxter Healthcare Corp · Jul 1993