Cleared Special

K022410 - SAPH-LOOP LIGATING LOOP
(FDA 510(k) Clearance)

K022410 · Genzyme Biosurgery · General & Plastic Surgery
Aug 2002
Decision
27d
Days
Class 2
Risk

K022410 is an FDA 510(k) clearance for the SAPH-LOOP LIGATING LOOP. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT).

Submitted by Genzyme Biosurgery (Fall River, US). The FDA issued a Cleared decision on August 20, 2002, 27 days after receiving the submission on July 24, 2002.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K022410 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2002
Decision Date August 20, 2002
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000