Surgimed Breast Localization Needle Wire Set
FDA 510(k) K936226 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK936226
Submission
- Device name
- Surgimed Breast Localization Needle Wire Set
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Oakland, NJ, US - Received
- December 29, 1993
- Decision date
- March 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDC – Instrument, Surgical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| 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 |
| K903649 | Bradley Tenaculum HolderKDC · Traditional | Marlo Surgical Technology | 11/02/1990SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | Richard-Allan Medical Ind., Inc. | 05/03/1990SE |
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| K961847 | Hemashield Vantage (Vascular GraftDSY · Traditional | 01/22/1997ST |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | 09/10/1996SE |
| K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular GraftDSY · Traditional | 05/30/1996ST |
| K952884 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 02/21/1996SE |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | 02/14/1996SE |
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Questions and answers
When was Surgimed Breast Localization Needle Wire Set cleared by the FDA?
Surgimed Breast Localization Needle Wire Set (K936226) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 68 days after the submission was received.
What is the product code of K936226?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.