Endoscopic Sponge Carrier

FDA 510(k) K822194 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822194

Submission

Device name
Endoscopic Sponge Carrier
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 23, 1982
Decision date
August 27, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FGS – Carrier, Sponge, Endoscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FGS

510(k)DeviceApplicantDecision
K933604QB II Blunt DissectorFGS · Traditional Joyce M. Shotwell, M.D.09/23/1993SE
K931854Endoscopic Blunt Dissecting InstrumentFGS · Traditional Mayaguez Medical Center08/10/1993SE
K923818O.R. Concepts' Irrigating KittnerFGS · Traditional O.R. Concepts, Inc.04/07/1993SE

More from O.R. Concepts, Inc.

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 Endoscopic Sponge Carrier cleared by the FDA?

Endoscopic Sponge Carrier (K822194) received a 510(k) decision of Substantially Equivalent on August 27, 1982, 35 days after the submission was received.

What is the product code of K822194?

The FDA product code is FGS – Carrier, Sponge, Endoscopic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.