Rowe Shoulder Instr. for Bankhart Repair
FDA 510(k) K820344 · New England Surgical Instrument Corp.
510(k) numberK820344
Submission
- Device name
- Rowe Shoulder Instr. for Bankhart Repair
- Applicant
- New England Surgical Instrument Corp.
Mchenry, IL, US - Received
- February 8, 1982
- Decision date
- March 8, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTD – Forceps
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051281 | The Needle CatcherHTD · Traditional | E.D.Medical , Ltd. | 09/08/2005SE |
| K974595 | Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974594 | Semkin Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974593 | Semkin Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | Marlo Surgical Technology | 10/23/1991SE |
| K911180 | Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K895212 | Tik ExtraktorHTD · Traditional | Instruments of Sweden, Inc. | 09/27/1989SE |
| K890373 | Hemorrhoidal ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890369 | Gall Stone ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890263 | Cilia ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
More from Kinetic Medical Products
| 510(k) | Device | Decision |
|---|---|---|
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | 09/15/1989SE |
| K895331 | Electrosurgical ElectrodeJOS · Traditional | 09/15/1989SE |
| K883963 | Raney and Leroy-Raney Scalp ClipHBO · Traditional | 10/07/1988SE |
| K883396 | Handswitching Monopolar PencilGEI · Traditional | 09/13/1988SE |
| K880863 | Bipolar Micro Coagulator Models 25-1000 & 25-1200GEI · Traditional | 04/19/1988SE |
| K880859 | Surgical BursGFF · Traditional | 03/21/1988SE |
| K872271 | Various Sizes & Styles of Monopolar ForcepsGEN · Traditional | 06/26/1987SE |
| K872209 | Arthroplasty MalletHXL · Traditional | 06/23/1987SE |
| K864770 | Suction TubeFFA · Traditional | 02/24/1987SE |
| K864775 | Chisel (Osteotome, Gouge, Etc.)EMM · Traditional | 02/12/1987SE |
Questions and answers
When was Rowe Shoulder Instr. for Bankhart Repair cleared by the FDA?
Rowe Shoulder Instr. for Bankhart Repair (K820344) received a 510(k) decision of Substantially Equivalent on March 8, 1982, 28 days after the submission was received.
What is the product code of K820344?
The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.