Endoscopic Applicator, 41 cm

FDA 510(k) K172672 · Micromedics, Inc. (D/B/A Nordson Medical)

Substantially Equivalent

510(k) numberK172672

Submission

Device name
Endoscopic Applicator, 41 cm
Applicant
Micromedics, Inc. (D/B/A Nordson Medical)
St. Paul, MN, US
Received
September 5, 2017
Decision date
October 6, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Endoscopic Applicator, 41 cm cleared by the FDA?

Endoscopic Applicator, 41 cm (K172672) received a 510(k) decision of Substantially Equivalent on October 6, 2017, 31 days after the submission was received.

What is the product code of K172672?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.