Forceps for Use with Rigid Endoscopes

FDA 510(k) K822193 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822193

Submission

Device name
Forceps for Use with Rigid Endoscopes
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 23, 1982
Decision date
August 24, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K990561Optical ForcepsJEK · Traditional Pilling Weck Surgical05/14/1999SE
K822198Malleus NippersJEK · Traditional Kelleher Corp.08/25/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K822618Emergency Tracheostomy Instrument SetLJW · Traditional 01/28/1983SE
K822268Nagashima Ns-Iii ElectronystagmographGWN · Traditional 01/28/1983SE
K823083Electrosurgical UnitGEI · Traditional 12/07/1982SE
K823111Nystymograph AccessGNN · Traditional 11/22/1982SE
K822252ENT Treatment UnitsETF · Traditional 11/22/1982SE
K822272Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional 11/10/1982SE
K822017Tympanostomy Tubes & Various TypesETD · Traditional 10/27/1982SE
K822257Various Types of Light Source HandlesEOQ · Traditional 10/26/1982SE
K822259Laryngeal SpatulasEQH · Traditional 10/22/1982SE
K822004Face ShieldsKNT · Traditional 10/20/1982SE

Questions and answers

When was Forceps for Use with Rigid Endoscopes cleared by the FDA?

Forceps for Use with Rigid Endoscopes (K822193) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 32 days after the submission was received.

What is the product code of K822193?

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