Cleared Traditional

K933171 - INMAN IRRIGATION TAPERED PROBE
(FDA 510(k) Clearance)

Apr 1994
Decision
304d
Days
Class 1
Risk

K933171 is an FDA 510(k) clearance for the INMAN IRRIGATION TAPERED PROBE. This device is classified as a Syringe, Irrigating (non Dental) (Class I - General Controls, product code KYZ).

Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on April 29, 1994, 304 days after receiving the submission on June 29, 1993.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K933171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date April 29, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6960