Kaiser No Cannula Thoracoscopy/Laparoscopy Instr
FDA 510(k) K925198 · Pilling Co.
510(k) numberK925198
Submission
- Device name
- Kaiser No Cannula Thoracoscopy/Laparoscopy Instr
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- October 16, 1992
- Decision date
- February 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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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| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
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| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
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| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
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| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
| K882930 | Laser Laryngoscope Dedo Articula. & Feder Dedo ExCCW · Traditional | 08/16/1988SE |
Questions and answers
When was Kaiser No Cannula Thoracoscopy/Laparoscopy Instr cleared by the FDA?
Kaiser No Cannula Thoracoscopy/Laparoscopy Instr (K925198) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 119 days after the submission was received.
What is the product code of K925198?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.