Percuvance(R) Percutaneous Surgical System— 510(k) K143299
Substantially EquivalentTeleflexmedical, Inc.
FDA 510(k) clearance K143299 for Percuvance(R) Percutaneous Surgical System, Substantially Equivalent on 2015-01-21. Applicant: Teleflexmedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflexmedical, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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More clearances from Teleflexmedical, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143299
K-number listed on FDA's recall record- Z-0058-2017 — Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
- Z-0059-2017 — Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.