Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
FDA 510(k) K150253 · Taiwan Surgical Corporation
510(k) numberK150253
Submission
- Device name
- Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
- Applicant
- Taiwan Surgical Corporation
Zhubei City, TW - Received
- February 3, 2015
- Decision date
- April 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | 08/25/2026SE |
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| K253903 | InnoClip Disposable Clip ApplierFZP · Special | 12/22/2025SE |
| K253781 | InnoClip Clip ApplierFZP · Special | 12/22/2025SE |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical TrocarGCJ · Traditional | 03/22/2023SE |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip ApplierFZP · Traditional | 01/04/2022SE |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,LFZP · Traditional | 11/06/2015SE |
Questions and answers
When was Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm cleared by the FDA?
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm (K150253) received a 510(k) decision of Substantially Equivalent on April 1, 2015, 57 days after the submission was received.
What is the product code of K150253?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.