Burke Congenital Thoracoscopy Instruments
FDA 510(k) K962771 · Pilling Weck, Inc.
510(k) numberK962771
Submission
- Device name
- Burke Congenital Thoracoscopy Instruments
- Applicant
- Pilling Weck, Inc.
Fort Washington, PA, US - Received
- July 16, 1996
- Decision date
- November 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 09/13/1989SE |
More from Cardiac Pacemakers, Inc.
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|---|---|---|
| K990547 | Pilling Weck Surgical Y Stent ForcepsEOQ · Traditional | 04/27/1999SE |
| K974250 | Versastat Multipolar Scissors and CablesGEI · Traditional | 02/11/1998SE |
| K945520 | Hemoclip EcosystemGCJ · Traditional | 01/27/1995SE |
| K944552 | Pilling Weck M-20 Disposable Automatic HemoclipFZP · Traditional | 11/07/1994SE |
| K943719 | Visistat StaplerGDT · Traditional | 08/24/1994SE |
Questions and answers
When was Burke Congenital Thoracoscopy Instruments cleared by the FDA?
Burke Congenital Thoracoscopy Instruments (K962771) received a 510(k) decision of Substantially Equivalent on November 19, 1996, 126 days after the submission was received.
What is the product code of K962771?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.