Marlow/Reddick Laparoscopic Grasping Forceps
FDA 510(k) K913964 · Marlo Surgical Technology
510(k) numberK913964
Submission
- Device name
- Marlow/Reddick Laparoscopic Grasping Forceps
- Applicant
- Marlo Surgical Technology
Willoughby, OH, US - Received
- September 5, 1991
- Decision date
- October 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K890262 | Lung ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
More from Kinetic Medical Products
| 510(k) | Device | Decision |
|---|---|---|
| K960810 | Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X…HET · Traditional | 10/21/1996SE |
| K962273 | Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMFD · Traditional | 07/31/1996SE |
| K924611 | Irrigation Pump and Tubing SetHET · Traditional | 06/30/1994SE |
| K932832 | Primus Insulated ForcepsHET · Traditional | 02/25/1994SE |
| K932634 | Nu-Tip(Tm) Forceps:Graspers/Dissectors/SuturesHET · Traditional | 02/25/1994SE |
| K920611 | Marlow Laparoscopic Grasping ForcepGCJ · Traditional | 04/20/1993SE |
| K914153 | Ott Insufflator Filter Plus/Tubing SetHIF · Traditional | 04/02/1992SE |
| K914869 | Marlow Laparoscopic ScissorsGCJ · Traditional | 01/15/1992SE |
| K913954 | Marlow/Reddick Laparoscopic Needle HoldersGCJ · Traditional | 12/18/1991SE |
| K914872 | Marlow Suction/Irrigation ProbesGSJ · Traditional | 11/19/1991SE |
Questions and answers
When was Marlow/Reddick Laparoscopic Grasping Forceps cleared by the FDA?
Marlow/Reddick Laparoscopic Grasping Forceps (K913964) received a 510(k) decision of Substantially Equivalent on October 23, 1991, 48 days after the submission was received.
What is the product code of K913964?
The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.