Cleared Traditional

NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.

K931501 · Numed Technologies, Inc. · Obstetrics & Gynecology
Jan 1994
Decision
292d
Days
Class 2
Risk

About This 510(k) Submission

K931501 is an FDA 510(k) clearance for the NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST., a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Numed Technologies, Inc. (Independence, US). The FDA issued a Cleared decision on January 11, 1994, 292 days after receiving the submission on March 25, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K931501 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1993
Decision Date January 11, 1994
Days to Decision 292 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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