Abdominal/Vascular Retractor-Split Wishbone 163000
FDA 510(k) K874243 · Pilling Co.
510(k) numberK874243
Submission
- Device name
- Abdominal/Vascular Retractor-Split Wishbone 163000
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- October 16, 1987
- Decision date
- November 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | 11/21/1991SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
Questions and answers
When was Abdominal/Vascular Retractor-Split Wishbone 163000 cleared by the FDA?
Abdominal/Vascular Retractor-Split Wishbone 163000 (K874243) received a 510(k) decision of Substantially Equivalent on November 13, 1987, 28 days after the submission was received.
What is the product code of K874243?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.