Pilling Laparoscopic Instrumentation
FDA 510(k) K934427 · Pilling Co.
510(k) numberK934427
Submission
- Device name
- Pilling Laparoscopic Instrumentation
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- September 10, 1993
- Decision date
- January 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K002582 | Pilling E-Frazier Bipolar Suction TubeGEI · Traditional | 11/03/2000SE |
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| 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 |
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Questions and answers
When was Pilling Laparoscopic Instrumentation cleared by the FDA?
Pilling Laparoscopic Instrumentation (K934427) received a 510(k) decision of Substantially Equivalent on January 10, 1994, 122 days after the submission was received.
What is the product code of K934427?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.