4MM Cup Currette

FDA 510(k) K841979 · Stainless Mfg., Inc.

Substantially Equivalent

510(k) numberK841979

Submission

Device name
4MM Cup Currette
Applicant
Stainless Mfg., Inc.
Mchenry, IL, US
Received
May 14, 1984
Decision date
June 19, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTF – Curette
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code HTF

510(k)DeviceApplicantDecision
K890252Bone CuretteHTF · Traditional Kinetic Medical Products01/27/1989SE
K870778Acromed Wallie-Heinig CurettesHTF · Traditional Buckman Co., Inc.03/09/1987SE

More from Buckman Co., Inc.

510(k)DeviceDecision
K841980Side Cutting Serrated BladeHTZ · Traditional 08/15/1984SE
K841982Meniscotome 4MM & 5MMHTZ · Traditional 06/19/1984SE
K8419814MM & 5MM FileHTP · Traditional 06/19/1984SE
K841978Lateral Release Knife 5MM & 7MMHTZ · Traditional 06/19/1984SE
K8419775MM Dougle Edge Ring CuretteHTZ · Traditional 06/19/1984SE
K841976Hook Knife 4MM & 5MMHTZ · Traditional 06/19/1984SE
K841975Rosette Knife 4MMHTZ · Traditional 06/19/1984SE
K841974Retrograde Knife 4MM & 5MMHTZ · Traditional 06/19/1984SE
K841973Banana Knife SerratedHTZ · Traditional 06/19/1984SE
K841972Banana Knife - K841969-LABELINGHTZ · Traditional 06/19/1984SE

Questions and answers

When was 4MM Cup Currette cleared by the FDA?

4MM Cup Currette (K841979) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 36 days after the submission was received.

What is the product code of K841979?

The FDA product code is HTF – Curette, a Class I (low risk) device regulated under 21 CFR 878.4800.