Reprocessed Ethicon Ets Endoscopic Linear Cutters

Q: What is the product code of K070859?

The FDA product code is NLL – Staple, Implantable, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4750.

FDA 510(k) K070859 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK070859

Submission

Device name: Reprocessed Ethicon Ets Endoscopic Linear Cutters
Applicant: Sterilmed, Inc.
Maple Grove, MN, US
Received: March 28, 2007
Decision date: September 12, 2007
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NLL – Staple, Implantable, Reprocessed
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4750
Specialty: General, Plastic Surgery

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other 510(k)s with product code NLL

510(k)	Device	Applicant	Decision
K070930	Reprocessed Autosuture Gia Endoscopic StaplersNLL · Traditional	Sterilmed, Inc.	10/18/2007SE
K033578	Reprocessed Reloadable Cutters, Staplers, and AppliersNLL · Traditional	Clearmedical, Inc.	07/11/2005SE

More from Clearmedical, Inc.

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Questions and answers

When was Reprocessed Ethicon Ets Endoscopic Linear Cutters cleared by the FDA?

Reprocessed Ethicon Ets Endoscopic Linear Cutters (K070859) received a 510(k) decision of Substantially Equivalent on September 12, 2007, 168 days after the submission was received.

What is the product code of K070859?

The FDA product code is NLL – Staple, Implantable, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4750.