Optical Forceps

FDA 510(k) K990561 · Pilling Weck Surgical

Substantially Equivalent

510(k) numberK990561

Submission

Device name
Optical Forceps
Applicant
Pilling Weck Surgical
Fort Washington, PA, US
Received
February 22, 1999
Decision date
May 14, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JEK – Forceps, Biopsy, Bronchoscope (Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4680
Specialty
Ear, Nose, Throat

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code JEK

510(k)DeviceApplicantDecision
K822198Malleus NippersJEK · Traditional Kelleher Corp.08/25/1982SE
K822193Forceps for Use with Rigid EndoscopesJEK · Traditional Kelleher Corp.08/24/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K992476Pilling Weck Surgical Heart Stabilizer Removable PadsMWS · Traditional 09/13/2000SE
K992174Pilling Weck Surgical Aortic Spoon-Jaw ClampDXC · Traditional 03/23/2000SE
K990935Jackson Esophageal DilatorKNQ · Traditional 05/17/1999SE
K982128Shikani-French Speaking ValveJOH · Traditional 10/23/1998SE

Questions and answers

When was Optical Forceps cleared by the FDA?

Optical Forceps (K990561) received a 510(k) decision of Substantially Equivalent on May 14, 1999, 81 days after the submission was received.

What is the product code of K990561?

The FDA product code is JEK – Forceps, Biopsy, Bronchoscope (Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.