Bradley Tenaculum Holder
FDA 510(k) K903649 · Marlo Surgical Technology
510(k) numberK903649
Submission
- Device name
- Bradley Tenaculum Holder
- Applicant
- Marlo Surgical Technology
Willoughby, OH, US - Received
- August 13, 1990
- Decision date
- November 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDC – Instrument, Surgical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDC
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|---|---|---|---|
| K943229 | Disposable Surgical Scissors and ForcepsKDC · Traditional | Y.M.K. International Co., Ltd. | 08/19/1994SE |
| K936226 | Surgimed Breast Localization Needle Wire SetKDC · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/07/1994SE |
| K920153 | Thermuff BagKDC · Traditional | Techstyles | 07/01/1992SE |
| K920263 | Manual Surgical InstrumentsKDC · Traditional | Phoenix Instruments Div. | 05/06/1992SE |
| K915064 | Disposable Cautery Abrasive PadKDC · Traditional | American Medical Mfg., Inc. | 03/11/1992SE |
| K914960 | Instrument OrganizerKDC · Traditional | O.R. Concepts, Inc. | 02/28/1992SE |
| K912834 | Shur-GripKDC · Traditional | Inman Medical Corp. | 07/26/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | Applied Vascular Devices, Inc. | 02/27/1991SE |
| K905240 | VesseloopsKDC · Traditional | Sparta Surgical Corp. | 02/06/1991SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | Richard-Allan Medical Ind., Inc. | 05/03/1990SE |
More from Richard-Allan Medical Ind., Inc.
| 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 Bradley Tenaculum Holder cleared by the FDA?
Bradley Tenaculum Holder (K903649) received a 510(k) decision of Substantially Equivalent on November 2, 1990, 81 days after the submission was received.
What is the product code of K903649?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.