Saph-Loop Ligating Loop

FDA 510(k) K022410 · Genzyme Biosurgery

Substantially Equivalent

510(k) numberK022410

Submission

Device name
Saph-Loop Ligating Loop
Applicant
Genzyme Biosurgery
Fall River, MA, US
Received
July 24, 2002
Decision date
August 20, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5000
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Saph-Loop Ligating Loop cleared by the FDA?

Saph-Loop Ligating Loop (K022410) received a 510(k) decision of Substantially Equivalent on August 20, 2002, 27 days after the submission was received.

What is the product code of K022410?

The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.